Devices and methods for using medicament devices

ABSTRACT

Disclosed herein are devices and methods for the use of medicament devices. The devices and methods may be used to detect or sense one or more parameters of a medicament device, for instance, shake parameters, actuation parameters, or inhalation airflow parameters. The devices and methods may be used to indicate to a user that the medicament device is in an appropriate condition for actuation of the medicament device. The devices and methods may be used to indicate to a user that the medicament device is in a condition to deliver an intended dosage range of a formulation. The devices and methods may further be used to guide a user through proper usage of a medicament device.

CROSS-REFERENCE

This application is a continuation application of International PatentApplication No. PCT/US2017/034824, filed May 26, 2017, which claims thebenefit of U.S. Provisional Application Nos. 62/342,843, filed May 27,2016; 62/439,595, filed Dec. 28, 2016; and 62/465,701, filed Mar. 1,2017, which applications are incorporated herein by reference in theirentirety.

BACKGROUND OF THE INVENTION

Inhaler and nasal devices may require specific handling such as propershaking and proper actuation in order to release an intended dosagerange of a drug. Poor handling by caregivers and patients and improperinhalation technique is associated with overdosed medication deliveryand decreased medication delivery, and poor disease control. User errorof inhaler and nasal devices is a critical public health concern and itis estimated that up to 92% of patients using pressurized metered doseinhalers (pMDIs) and up to 54% of patients using dry powder inhalers maybe using their inhalers incorrectly. Correct inhaler technique involvessome common steps for all devices (e.g., dose preparation, deviceorientation, full exhalation, deep inhalation, and breath hold).However, dose preparation, such as priming and re-priming the device,shaking the device, and device orientation differ between devices.Furthermore, the characteristics of the device and the formulation ofthe drug, each of which vary between products, may be important factorsin determining the correct handling technique to ensure an intendeddosage of drug is being delivered. Moreover, usage instructions such as“shake well” or “shake for 5 seconds,” are interpreted differently inpractice among device users adding to dosage problems caused by improperdose preparation and device use technique. Similar types of errors mayoccur with caregivers and patients using nasal devices to deliver a drugformulation.

SUMMARY OF THE INVENTION

In one aspect, a sensor device is provided for guiding usage of amedicament device, the sensor device comprising: a coupler for couplingto the medicament device, wherein the medicament device is selected froma plurality of different types of medicament devices; one or moresensors for detecting use of the medicament device; a processorconfigured to: automatically process one or more parameters associatedwith the medicament device; and output a signal based on the one or moreparameters; and an indicator configured to: operably receive the signal;and output a guidance to a user of the medicament device, wherein theguidance varies depending on a type of medicament device that isselected. The guidance may vary in a duration of shaking a medicamentdevice, a shake-to-fire interval, a wait time between actuations, anumber of priming steps, a number of re-priming steps, and a durationuntil re-priming steps. The duration of shaking the medicament devicemay vary between 0 and 30 seconds. The wait time between actuations mayvary between 0 to 60 seconds. The number of priming steps may varybetween 0 and 5. The number of re-priming steps may vary between 0 and5. The duration until re-priming steps may vary between 0 and 30 days.The shake-to-fire interval may vary from 0 to 30 seconds. The guidancemay comprise an auditory indication. The guidance may comprise a visualindication. The coupler may comprise a receiving port. The receivingport may comprise an electrical interface. The receiving port may beconfigured to removably receive a complementary protrusion of an adaptercomprising a memory storing the one or more parameters associated withthe medicament device. The coupler may comprise one or more latch pointsfor receiving one or more latches of an adapter comprising an adhesiveconfigured to couple to the medicament device. The sensor device may beconfigured to be used with 5 or more different types of medicamentdevices. The sensor device may be configured to be used for a durationof more than 6 months. The one or more sensors may comprise anaccelerometer, a barometer, a temperature sensor, a magnetometer, anambient light sensor, or a global positioning system (GPS). The one ormore sensors may comprise the accelerometer, and the accelerometer maybe configured to be located along a central axis of the medicamentdevice. The barometer may be located in a pressure sensing cavity. Thepressure sensing cavity may allow a bidirectional flow of air in and outof the pressure sensing cavity. The bidirectional flow of air may bethrough a single opening in the pressure sensing cavity. The pressuresensing cavity may comprise a volume of approximately 10 mm³. Thepressure sensing cavity may comprise an opening for coupling to apressure tap tube. The sensor device may comprise an element for turningthe sensor device on or off. The element may be located at a proximalend of the sensor device. The indicator may comprise a speaker. Theindicator may comprise a light emitting diode (LED). The indicator maycomprise a visual display. The sensor device may comprise an interfacefor communicating with an external device. The sensor device maycomprise a size of approximately 10 cm′. The medicament device maycomprise a canister used with an inhaler. The inhaler may be is apressurized dose metered inhaler.

In another aspect, a kit is provided comprising: a sensor device of anyof the above, and instructions for coupling and/or decoupling the sensordevice to an adapter comprising a memory storing the one or moreparameters associated with the medicament device.

In another aspect, an adapter is provided for guiding usage of amedicament device, the adapter comprising: a first coupler for couplingto the medicament device; a memory storing one or more parametersassociated with the medicament device; and a second coupler for couplingto a sensor device, wherein the sensor device is configured to output aguidance to a user of the medicament device. In another aspect, a kit isprovided comprising: the adapter; and instructions for coupling and/ordecoupling the adapter to a medicament device selected from a pluralityof different types of medicament devices. The adapter may be configuredto guide usage of a single type of medicament device. The second couplermay comprise a protrusion. The protrusion may comprise an electricalinterface. The protrusion may be complementary to a receiving port of asensor device comprising one or more sensors for detecting use of themedicament device. The first coupler may comprise an adhesive. Theadapter may further comprise one or more processors operably coupled tothe memory. The adapter may comprise a pressure tap tube. The pressuretap tube may be hollow. The pressure tap tube may comprise a proximalportion located on a first surface of the adapter and a distal portionlocated away from a second surface opposite the first surface. Theproximal portion may comprise a sealing element. The sealing element maybe an “O” ring. The distal portion may comprise one or more holes. Theone or more holes may be located on a side surface of the pressure taptube. The pressure tap tube may be configured to run alongside alongitudinal axis of the medicament device. The adapter may comprise anauthenticator. The authenticator may be configured to authenticate thesensor device and/or the adapter. The adapter may be configured tocouple to the sensor device via a snap on mechanism. The adapter may beconfigured to be used for at least 60 actuations. The medicament devicemay comprise a canister used with an inhaler.

In yet another aspect, a method is provided for using a sensor deviceconfigured to couple to a plurality of different types of medicamentdevices, the method comprising: coupling the sensor device to a firstmedicament device; processing one or more parameters associated with thefirst medicament device; guiding usage of the first medicament devicebased on the processed one or more parameters associated with the firstmedicament device; decoupling the sensor device from the firstmedicament device; coupling the sensor device to a second medicamentdevice, wherein the second medicament device differs in a type ofmedicament device from the first medicament device; processing one ormore parameters associated with the second medicament device; andguiding usage of the second medicament device based on the processed oneor more parameters associated with the second medicament device, whereinguiding usage of the second medicament device differs from guiding usageof the first medicament device. Guiding usage of the second medicamentdevice may differ from guiding usage of the first medicament device in aduration of shaking a medicament device, a shake-to-fire interval, await time between actuations, a number of priming steps, a number ofre-priming steps, or a duration until re-priming steps. The duration ofshaking the medicament device may vary between 0 and 30 seconds. Thewait time between actuations may vary between 0 to 60 seconds. Thenumber of priming steps may vary between 0 and 5. The number ofre-priming steps may vary between 0 and 5. The duration until re-primingsteps may vary between 0 and 30 days. The shake-to-fire interval mayvary between 0 and 30 seconds. Coupling the sensor device to the firstmedicament device may comprise coupling the sensor device to a firstadapter coupled to the first medicament device, wherein the firstadapter comprises a first memory storing a first set of parametersassociated with the first medicament device. Coupling the sensor deviceto the second medicament device may comprise coupling the sensor deviceto a second adapter coupled to the second medicament device, wherein thesecond adapter comprises a second memory storing a second set ofparameters associated with the second medicament device, wherein thesecond set of parameters differs from the first set of parameters. Themedicament device may comprise a canister used with an inhaler.

In another aspect, a method is provided for measuring usage of aninhaler using one or more sensors, the method comprising: with aid ofthe one or more sensors: measuring a duration of shaking the inhaler;measuring a duration of a time subsequent to the shaking; measuring aninhalation of a user using inhaler; measuring an actuation of theinhaler; and measuring a duration of a hold down time of the actuation.The one or more sensors may output an indication subsequent to eachmeasuring step when a predetermined threshold has been reached. Theoutput may be a visual output that indicates to the user of the inhalerto move onto a next step. The output may be an auditory output thatindicates to the user of the inhaler to move onto a next step. The oneor more sensors may be further configured to measure an orientation ofthe inhaler. The sensor may output an indication of an incorrectorientation when the inhaler is outside a predetermined orientation. Theone or more sensors may be further configured to track a remainingnumber of actuations for the inhaler. The sensor may output anindication of a low number of dosages remaining for the inhaler when theinhaler is at or below a predetermined number of dosages remaining. Theone or more sensors may comprise an accelerometer, a barometer, atemperature sensor, a magnetometer, an ambient light sensor, or globalpositioning system (GPS). The inhaler may comprise a medicament device.The medicament device may be a canister of the inhaler. The one or moresensors may comprise a sensor located external to the inhaler. The oneor more sensors may be located on a mobile device.

In another aspect, a device is provided for monitoring usage of amedicament device, the device comprising: a) an adapter, wherein theadapter comprises a memory storing a set of parameters specific to atype of the medicament device; and b) a sensor device separable from,and in operable communication with the adapter, wherein the sensordevice is configured to be used with a plurality of different types ofadapters each comprising a unique set of parameters specific todifferent types of medicament devices, wherein the device is configuredto produce an output based on the set of parameters. The device mayfurther comprise the medicament device. The medicament device may be acanister used with an inhaler. The adapter may be configured to coupleto an exterior of the canister, and the sensor device may be configuredto couple indirectly to the canister via the adapter. The sensor devicemay comprise an accelerometer configured to be located along a centralline axis of the medicament device when the adapter and the sensordevice are coupled to the medicament device. The sensor device maycomprise a pressure sensing cavity comprising a single opening. Theadapter may comprise a pressure tap tube configured to couple to thesingle opening. The pressure sensing cavity may comprise a barometer.The sensor device may comprise a receiving port, and the adapter maycomprise a protrusion complementary to the receiving port. The receivingport and the protrusion may each comprise an electrical interface. Theoutput may be a feedback provided to a user based on usage of themedicament device. The feedback may guide the user on how to properlyadminister the medicament device in real-time. The output may beproduced when at least one of the set of parameters has met apredetermined threshold. The output may be produced when at least one ofthe set of parameters is outside a threshold range. The sensor devicemay be configured to be operable with one or more different medicamentdevices. The sensor device may be reusable. The adapter may bedisposable. The medicament device may be used with an inhaler or nasaldevice. The inhaler or nasal device may be a pressurized metered doseinhaler (pMDI) or a dry powder inhaler. The set of parameters maycomprise one or more shake parameters. The one or more shake parametersmay comprise: shake duration, shake angle, shake frequency,shake-to-fire interval, shake orientation, and any combination thereof.The set of parameters may comprise one or more actuation parameters. Theone or more actuation parameters may comprise: compression velocity,compression acceleration, actuation hold time, decompression velocity,decompression acceleration, actuation stroke length, and any combinationthereof. The set of parameters may comprise one or more inhalationairflow parameters. The one or more inhalation airflow parameters maycomprise: inspiratory airflow rate, inhaled volume, inflow velocity, andany combination thereof. The medicament device may contain a formulationof a drug. The output may be produced when at least one of the set ofparameters has met a predetermined threshold, and the predeterminedthreshold may be determined based on a composition of the formulation ofa drug, one or more characteristics of the medicament device, or both.The formulation may comprise one or more excipients. The formulation maycomprise no excipients. The adapter may be affixed to a housing or acanister of the medicament device. The adapter may be permanentlyaffixed to a surface of the housing or canister. The adapter may beremovably affixed to a surface of the housing or canister. The sensordevice may be affixed to the adapter. The one or more outputs maycomprise a visual indication, an audible indication or both. The visualindication may comprise: a presence or absence of a light, a colorchange of a light, a flashing of a light, and any combination thereof.The visual indication may be produced by a light-emitting diode (LED).The visual indication may be produced by a LCD or LED display. Theoutput may comprise data. The data may be collected and stored by thedevice. The data may be transmitted to or read from a mobile device, acomputer, a cloud application, or any combination thereof. The one ormore sensors may be selected from the group comprising: anaccelerometer, a barometer, a temperature sensor, a magnetometer, anambient light sensor, or a global positioning system (GPS).

In yet another aspect, a method is provided for using an inhaler ornasal device with aid of a sensor, the method comprising: a) shaking theinhaler or nasal device; b) measuring a shake-to-fire interval foractuating the inhaler or nasal device using the sensor; c) actuating theinhaler or nasal device when the sensor produces an output, wherein whenthe sensor detects a beginning of the shake-to-fire interval, the sensorproduces the output.

In another aspect, a method is provided for using an inhaler or nasaldevice with aid of a sensor, the method comprising: a) compressing theinhaler or nasal device for a period of time, wherein the period of timecomprises an actuation hold time window; and b) decompressing theinhaler or nasal device when the sensor produces an output, wherein whenthe sensor detects an end of the actuation hold time window, the sensorproduces the output.

In another aspect, a device is provided for monitoring usage of amedicament device comprising: a) an adapter comprising: a distal endcomprising a first adapter coupler for coupling to the medicamentdevice; a memory storing one or more parameters associated with themedicament device; a proximal end comprising a second adapter couplerfor coupling to a sensor device, wherein the second adapter couplercomprises a protrusion comprising an electrical interface; and apressure tap tube, wherein the pressure tap tube comprises a first endon the proximal end side of the adapter and a second end locateddistally away from the distal end side of the adapter; and b) a sensordevice removably coupled to the adapter, wherein the sensor devicecomprises: a mating surface for mating with the proximal end of theadapter, comprising: a receiving port comprising an electricalinterface, wherein the receiving port is complementary to the protrusionand is configured to receive the protrusion; and an opening configuredto receive the first end of the pressure tap tube; a pressure sensingcavity operably coupled to the opening, the pressure sensing cavitydefining an enclosed chamber with the opening and comprising abarometer; a processor operably coupled to the receiving port, theprocessor configured to: receive the one or more parameters associatedwith the medicament device from the adapter; automatically process theone or more parameters associated with the medicament device; and outputa signal based on the one or more parameters; and an indicatorconfigured to: operably receive the signal; and output a guidance to auser of the medicament device, wherein the guidance varies depending onthe one or more parameters that is received.

In another aspect, a kit is provided comprising: a sensor deviceaccording to any of the above; an adapter according to any of the above;and instructions for coupling and/or decoupling the sensor device andthe adapter to a medicament device selected from a plurality ofdifferent types of medicament devices.

In one aspect, a system is provided comprising a sensor for detectingone or more parameters of an inhaler or nasal device, wherein the sensoris in contact with the inhaler or nasal device and wherein the systemproduces one or more outputs when each of at least one of the one ormore parameters has met a predetermined threshold. In some cases, wheneach of at least one of the one or more parameters has met apredetermined threshold, the inhaler or nasal device, when actuated,delivers an intended dosage range of a drug. In some cases, the one ormore parameters comprises one or more shake parameters. In someexamples, the one or more shake parameters are selected from the groupconsisting of: shake duration, shake angle, shake frequency,shake-to-fire interval, and any combination thereof. In some instances,the one or more parameters comprise one or more actuation parameters. Insome examples, the one or more actuation parameters is selected from thegroup consisting of: compression velocity, compression acceleration,actuation hold time, decompression velocity, decompression acceleration,actuation stroke length, and any combination thereof. In some instances,the one or more parameters comprises one or more inhalation airflowparameters. In some examples, the one or more inhalation airflowparameters is selected from the group consisting of: inspiratory airflowrate, inhaled volume, inflow velocity, and any combination thereof. Insome cases, the inhaler or nasal device is a pressurized metered doseinhaler (pMDI) or a dry powder inhaler. In some cases, the inhaler ornasal device contains a formulation of a drug. In some cases, thepredetermined threshold is determined based on a composition of theformulation of a drug, one or more characteristics of the inhaler ornasal device, or both. In some cases, the formulation comprises one ormore excipients. In some cases, the formulation comprises no excipients.In some cases, the sensor is affixed to a holder or a canister of theinhaler or nasal device. In some cases, the sensor is permanentlyaffixed to the holder or canister. In some cases, the sensor isremovably affixed to the holder or canister. In some cases, the sensoris affixed to a surface of the holder or canister. In some cases, thesensor is embedded into the holder or canister. In some cases, the oneor more outputs comprises an indication. In some cases, the indicationis a visual indication, an audible indication or both. In some cases,the visual indication is selected from the group consisting of: apresence or absence of a light, a color change of a light, a flashing ofa light, and any combination thereof. In some examples, the indicationis produced by a light-emitting diode (LED). In some cases, the sensoris operably coupled to the inhaler or nasal device. In some cases, theone or more outputs comprises data. In some cases, the data is collectedand stored by the sensor. In some cases, the data is transmitted to orread from a mobile device, a computer, a cloud application, or anycombination thereof.

In another aspect, a system is provided comprising a sensor fordetecting a shake-to-fire interval for actuating an inhaler or nasaldevice, wherein the sensor is in contact with the inhaler or nasaldevice and wherein when the sensor detects the shake-to-fire interval,the system produces one or more outputs. In some cases, theshake-to-fire interval indicates a period of time during which theinhaler or nasal device, when actuated, delivers an intended dosagerange of a drug. In some cases, the shake-to-fire interval comprises afirst time point at the start of the shake-to-fire interval and a secondtime point at the end of the shake-to-fire interval. In some cases, theinhaler or nasal device contains a formulation of a drug. In some cases,the shake-to-fire interval is determined based on a composition of theformulation of a drug, one or more characteristics of the inhaler ornasal device, or both. In some cases, the formulation comprises one ormore excipients. In some cases, the formulation comprises no excipients.In some cases, the one or more outputs comprises an indication. In somecases, the one or more outputs is produced when the first time point isreached. In some cases, one or more additional outputs is produced whensecond time point is reached. In some cases, the indication is a visualindication, audible indication or both. In some cases, the visualindication is selected from the group consisting of: a presence orabsence of a light, a color change of a light, a flashing of a light,and any combination thereof. In some cases, the visual indication isproduced by a light-emitting diode (LED). In some cases, the sensorfurther detects one or more parameters of the inhaler or nasal device.In some cases, the one or more parameters comprises one or more shakeparameters. In some cases, the shake-to-fire interval is a period oftime after a predetermined threshold of the one or more parameters ismet. In some examples, the one or more shake parameters is selected fromthe group consisting of: shake duration, shake angle, shake frequency,shake-to-fire interval, and any combination thereof. In some cases, thesensor is operably coupled to the inhaler or nasal device. In somecases, the inhaler or nasal device cannot be actuated outside of theshake-to-fire interval. In some cases, the inhaler or nasal device isautomatically actuated when the shake-to-fire interval is detected. Insome cases, the inhaler or nasal device is automatically actuated whenthe one or more outputs is produced. In some cases, the sensor isaffixed to a holder or a canister of the inhaler or nasal device. Insome cases, the sensor is permanently affixed to the holder or canister.In some cases, the sensor is removably affixed to the holder orcanister. In some cases, the sensor is affixed to a surface of theholder or canister. In some cases, the sensor is embedded into theholder or canister. In some cases, the inhaler or nasal device is apressurized metered dose inhaler (pMDI) or a dry powder inhaler. In somecases, the one or more outputs comprises data. In some cases, the datais collected and stored by the sensor. In some cases, the data istransmitted to or read from a mobile device, a computer, a cloudapplication or any combination thereof.

In another aspect, a method is provided for using an inhaler or nasaldevice comprising a system, wherein the system comprises a sensor incontact with the inhaler or nasal device, the method comprising: a)shaking the inhaler or nasal device, wherein the shaking comprises oneor more shake parameters; and b) actuating the inhaler or nasal devicewhen a predetermined threshold of the one or more shake parameters ismet, wherein when the sensor detects the predetermined threshold hasbeen met, the system produces one or more outputs. In some instances,the one or more shake parameters is selected from the group consistingof: shake duration, shake angle, shake frequency, shake-to-fireinterval, and any combination thereof. In some cases, the one or moreoutputs comprise an indication. In some cases, the indication is avisual indication, an audible indication or both. In some cases, theactuating releases an intended dosage of a drug. In some cases, themethod further comprises during the actuating, the sensor or anadditional sensor detects one or more actuation parameters. In somecases, when the sensor or the additional sensor detects a predeterminedthreshold of the one or more actuation parameters, the system producesone or more additional outputs. In some cases, the one or more actuationparameters is selected from the group consisting of: compressionvelocity, compression acceleration, actuation hold time, decompressionvelocity, decompression acceleration, actuation stroke length, and anycombination thereof. In some cases, the inhaler or nasal device is apressurized metered dose inhaler (pMDI) or a dry powder inhaler. In somecases, the inhaler or nasal device contains a formulation of a drug. Insome cases, the predetermined threshold is determined based on acomposition of the formulation of a drug, one or more characteristics ofthe inhaler or nasal device, or both. In some cases, the formulationcomprises one or more excipients. In some cases, the formulationcomprises no excipients. In some cases, the sensor is affixed to aholder or a canister of the inhaler or nasal device. In some cases, thesensor is permanently affixed to the holder or canister. In some cases,the sensor is removably affixed to the holder or canister. In somecases, the sensor is affixed to a surface of the holder or canister. Insome cases, the sensor is embedded into the holder or canister. In somecases, the visual indication is selected from the group consisting of: apresence or absence of a light, a color change of a light, a flashing ofa light, and any combination thereof. In some cases, the visualindication is produced by a light-emitting diode (LED). In some cases,the sensor is operably coupled to the inhaler or nasal device. In somecases, the one or more outputs comprises data. In some cases, the datais collected and stored by the sensor. In some cases, the data istransmitted to or read from a mobile device, a computer, a cloudapplication or any combination thereof.

In another aspect, a system is provided comprising a sensor fordetecting an actuation hold time window of an inhaler or nasal device,wherein the sensor is in contact with the inhaler or nasal device andwherein when the sensor detects the actuation hold time window, thesystem produces one or more outputs. In some cases, the actuation holdtime window comprises a length of time after which the inhaler or nasaldevice, when held in an actuated state, has delivered an intended dosagerange of a drug. In some cases, the actuation hold time window comprisesa first time point at the start of the actuation hold time window and asecond time point at the end of the actuation hold time window. In somecases, the inhaler or nasal device contains a formulation of a drug. Insome cases, the actuation hold time window is determined based on acomposition of the formulation of a drug, one or more characteristics ofthe inhaler or nasal device, or both. In some cases, the formulationcomprises one or more excipients. In some cases, the formulationcomprises no excipients. In some cases, the one or more outputscomprises an indication. In some cases, the indication is a visualindication, an audible indication or both. In some cases, the visualindication is selected from the group consisting of: a presence orabsence of a light, a color change of a light, a flashing of a light,and any combination thereof. In some cases, the visual indication isproduced by a light-emitting diode (LED). In some cases, the output isproduced when the second time point of the actuation hold time window isdetected. In some cases, the sensor further detects one or moreparameters of the inhaler or nasal device. In some cases, the one ormore parameters comprises one or more shake parameters. In some cases,the one or more shake parameters is selected from the group consistingof: shake duration, shake angle, shake frequency, shake-to-fireinterval, and any combination thereof. In some cases, the one or moreparameters comprises one or more actuation parameters. In some cases,the one or more actuation parameters is selected from the groupconsisting of: compression velocity, compression acceleration, actuationhold time, decompression velocity, decompression acceleration, actuationstroke length, and any combination thereof. In some cases, the sensor isoperably coupled to the inhaler or nasal device. In some cases, thesensor is affixed to a holder or a canister of the inhaler or nasaldevice. In some cases, the sensor is permanently affixed to the holderor canister. In some cases, the sensor is removably affixed to theholder or canister. In some cases, the sensor is affixed to a surface ofthe holder or canister. In some cases, the sensor is embedded into theholder or canister. In some cases, the inhaler or nasal device is apressurized metered dose inhaler (pMDI) or a dry powder inhaler. In somecases, the one or more outputs comprises data. In some cases, the datais collected and stored by the sensor. In some cases, the data istransmitted to or read from a mobile device, a computer, a cloudapplication or any combination thereof.

In another aspect, a method is provided for using an inhaler or nasaldevice comprising a system, wherein the system comprises a sensor incontact with the inhaler or nasal device, the method comprising: a)compressing the inhaler or nasal device for a period of time, whereinthe period of time comprises an actuation hold time window; b)decompressing the inhaler or nasal device when the system produces anoutput, wherein when the sensor detects the end of the actuation holdtime window, the system produces the output. In some cases, thecompressing releases an amount of a drug. In some cases, the methodfurther comprises, prior to the compressing, shaking the inhaler ornasal device. In some cases, the shaking comprises one or more shakeparameters. In some cases, the one or more shake parameters is selectedfrom the group consisting of: shake duration, shake angle, shakefrequency, shake-to-fire interval, and any combination thereof. In somecases, the system produces an additional output when a predeterminedthreshold of the one or more shake parameters has been met. In somecases, the decompressing occurs after an intended dosage range of a drughas been released from the inhaler or nasal device. In some cases, themethod further comprises during the actuating, the sensor detects one ormore actuation parameters. In some cases, the sensor produces anadditional output when a predetermined threshold of the one or moreactuation parameters has been met. In some cases, the one or moreactuation parameters is selected from the group consisting of:compression velocity, compression acceleration, actuation hold time,decompression velocity, decompression acceleration, actuation strokelength, and any combination thereof. In some cases, the inhaler or nasaldevice is a pressurized metered dose inhaler (pMDI) or a dry powderinhaler. In some cases, the inhaler or nasal device contains aformulation of a drug. In some cases, the actuation hold time window isdetermined based on a composition of the formulation of a drug, one ormore characteristics of the inhaler or nasal device, or both. In somecases, the formulation comprises one or more excipients. In some cases,the formulation comprises no excipients. In some cases, the sensor isaffixed to a holder or a canister of the inhaler or nasal device. Insome cases, the sensor is permanently affixed to the holder or canister.In some cases, the sensor is removably affixed to the holder orcanister. In some cases, the sensor is affixed to a surface of theholder or canister. In some cases, the sensor is embedded into theholder or canister. In some cases, the output comprises an indication.In some cases, the indication is a visual indication, an audibleindication or both. In some cases, the visual indication is selectedfrom the group consisting of: a presence or absence of a light, a colorchange of a light, a flashing of a light, and any combination thereof.In some cases, the visual indication is produced by a light-emittingdiode (LED). In some cases, the sensor is operably coupled to theinhaler or nasal device. In some cases, the output comprises data. Insome cases, the data is collected and stored by the sensor. In somecases, the data is transmitted to or read from a mobile device, acomputer, a cloud application or any combination thereof.

In another aspect, the disclosure provides for a device or componentsthereof, as illustrated in any one of FIG. 1A-C, 2A, 2B, 12A-D, or15A-E.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1A depicts a non-limiting example of a sensor and an adapter asdescribed herein. FIG. 1B depicts a non-limiting example of a method ofattaching a sensor and adapter to a medicament device as describedherein. FIG. 1C depicts a non-limiting example of a sensor and adapterattached to a medicament device as described herein.

FIG. 2A depicts a non-limiting example of a method of attaching a sensorto an adapter as described herein. FIG. 2B depicts a non-limitingexample of a sensor and one or more product-specific adapters asdescribed herein.

FIG. 3A, FIG. 3B, FIG. 3C, and FIG. 3D depict multiple views of a sensorpackage as described in accordance with various embodiments of thedisclosure. FIG. 3A depicts an exploded top view of a non-limitingexample of a sensor package in accordance with an embodiment of thedisclosure. FIG. 3B depicts an exploded bottom view of a non-limitingexample of a sensor package in accordance with an embodiment of thedisclosure. FIG. 3C depicts a top view of a non-limiting example of asensor package in accordance with an embodiment of the disclosure. FIG.3D depicts a bottom view of a non-limiting example of a sensor packagein accordance with an embodiment of the disclosure.

FIG. 4A, FIG. 4B, and FIG. 4C depict a non-limiting example of anadapter as described in accordance with various embodiments of thedisclosure. FIG. 4A depicts a top view of a non-limiting example of anadapter prior to coupling to an inhaler device in accordance with anembodiment of the disclosure. FIG. 4B depicts a top view of anon-limiting example of an adapter after coupling to an inhaler devicein accordance with an embodiment of the disclosure. FIG. 4C depicts anon-limiting example of an expanded view of a pressure tap tube asembodied on an adapter in accordance with an embodiment of thedisclosure.

FIG. 5A and FIG. 5B depict a non-limiting example of a sensor device andadapter coupled to an inhaler device. FIG. 5A depicts a non-limitingexample of an adapter coupled to an inhaler device prior to coupling ofa sensor device in accordance with an embodiment of the disclosure.

FIG. 5B depicts a non-limiting example of a sensor device and adaptercoupled to an inhaler device in accordance with an embodiment of thedisclosure.

FIG. 6A and FIG. 6B depict a non-limiting example of coupling of asensor device to an adapter. FIG. 6A depicts a non-limiting example of asensor device and an adapter prior to coupling in accordance with anembodiment of the disclosure. FIG. 6B depicts a non-limiting example ofa sensor device coupled to an adapter in accordance with an embodimentof the disclosure.

FIG. 7 depicts a non-limiting example of an expanded view of a pressuresensing cavity in accordance with an embodiment of the disclosure.

FIG. 8 depicts a non-limiting example of a pressure sensing cavity witha barometer located on a bottom surface of a circuit board in accordancewith an embodiment of the disclosure.

FIG. 9 depicts non-limiting examples of product-specific operatingparameters for specific medicament devices in accordance with anembodiment of the disclosure.

FIG. 10 depicts non-limiting examples of placement of a sensor and avisual indicator (e.g., LED) on an inhaler device.

FIG. 11 depicts a non-limiting example of positioning of anaccelerometer coincident with a long axis of an inhaler canister inaccordance with an embodiment of the disclosure.

FIG. 12A, FIG. 12B, FIG. 12C, and FIG. 12D depict non-limiting examplesof indications outputted by a system of the disclosure.

FIG. 13 depicts a non-limiting example workflow of a system as describedherein.

FIG. 14 depicts a non-limiting example workflow of a method of using thesystems described herein.

FIG. 15A, FIG. 15B, FIG. 15C, FIG. 15D, and FIG. 15E depict anon-limiting example of a method of using a device as described herein.

FIG. 16 depicts a non-limiting example of a computer system suitable tobe used with a device of the disclosure.

FIG. 17A, FIG. 17B, FIG. 17C, and FIG. 17D depict various views of anexemplary system as described herein. FIG. 17A depicts a non-limitingexample of a top view of a system as described herein. FIG. 17B depictsa non-limiting example of a side view of a system as described herein.FIG. 17C depicts a non-limiting example of a bottom view of a system asdescribed herein.

FIG. 17D depicts a non-limiting example of a system assembled onto apMDI canister as described herein.

DETAILED DESCRIPTION OF THE INVENTION

Disclosed herein are methods and devices for sensing or detecting one ormore parameters related to usage of a medicament device. In some cases,the medicament device is an inhaler or a nasal device. The methods anddevices may be used, for example, to sense or detect when a medicamentdevice is in a condition that is suitable for delivering an intendeddosage of a drug. Additionally or alternatively, the methods and devicesdescribed herein may guide a user through one or more steps of using amedicament device, for example, by providing feedback to the user basedon one or more usage parameters of the medicament device. Generally, theguidance may be provided to the user of a medicament device in order toassist the user in proper usage of the device. Devices and methodsdescribed herein may include any number of medicament devices, sensordevices, and/or product-specific adapters.

The term “medicament device” as used herein may refer to any device orapparatus configured to deliver a drug or a therapeutic to a user.Optionally, the medicament device may refer to a container or devicecontaining a medicament. In some non-limiting instances, the term“medicament device” as used herein may refer to an inhaler device or anasal device. In some cases, the term “medicament device” may refer toan Orally Inhaled and Nasal Drug Product (OINDP) or any componentthereof. The term “medicament device” as used herein may refer to themedicament device as a whole, or may refer to any component of themedicament device. By way of example only, the term “medicament device”may refer to an inhaler device, or may refer to a component of theinhaler device, such as a housing of the inhaler device, an actuator ofthe inhaler device, a mouthpiece of the inhaler device, or a canister ofmedicament contained within the housing of the inhaler device.

The terms “sensor package” and “sensor device” may be used hereininterchangeably and may refer to a device that may be used inconjunction with a medicament device for sensing one or more usageparameters of a medicament device. The sensor device may contain one ormore sensors, and additionally may contain any number of electroniccomponents, batteries, microprocessors, switches, buttons, circuitboards, and feedback systems such as auditory or visual outputs. Variousnon-limiting examples of sensor devices are described herein.

The terms “adapter”, “connector”, “product-specific adapter” and“product-specific connector” may be used herein interchangeably and mayrefer to a device that may be used to attach or couple a sensor deviceto the medicament device. The adapter or connector may be configured tocouple a sensor device to a medicament device, and may additionallycontain any number of electronic components. In some cases, the adaptermay comprise one or more product-specific operating parameters (PSOPs)that are specific for a particular medicament device. Variousnon-limiting examples of adapters are described herein.

The terms “product-specific operating parameters” or “PSOPs” may be usedherein interchangeably and may refer to specific parameters associatedwith a particular medicament device for proper usage of the device. Forexample, the PSOPs may refer to the number of times a medicament deviceshould be shaken prior to actuation, or the number of actuationsrequired to prime the medicament device prior to initial usage. Althoughvarious PSOPs have been described herein, it should be understood thatthe PSOPs for a particular medicament device will vary depending on avariety of factors, and thus the various embodiments described hereinare to be viewed as non-limiting examples only. PSOPs for a specificmedicament device may be provided by the manufacturer of the medicamentdevice (e.g., provided in an instruction sheet for the device or on thebox of the device) or may need to be determined empirically. In someinstances, the PSOPs are programmed or loaded onto the product-specificadapter as described herein.

The amount of drug released by a medicament device may be dependent on anumber of factors, for example, whether the device has been shakenproperly prior to actuation or whether a device user has actuated thedevice properly. Even further, the composition of the formulation (e.g.,drug, excipients, propellants) contained within the device, andcharacteristics of the device itself may be critical factors indetermining how much the device needs to be shaken prior to actuation orhow long the device needs to be in an actuated state to deliver anintended dosage range. Usage of medicament devices, and particularlyinhaler and nasal devices, are prone to user error, often resulting inan incorrect dosage of drug delivered. This may be especially relevantas different drug formulations, even if used in a same context (e.g.,with inhalers), may comprise very different usage parameters, forexample, as illustrated in FIG. 9. The devices and methods providedherein may be utilized to indicate to a user of a medicament device thatthe device is in a condition suitable to deliver the intended dosagerange of the formulation. The methods and devices described throughoutmay guide or instruct a user on how to operate the medicament deviceproperly, thereby improving the use of said device. In some instances,the methods and devices described throughout may guide or instruct auser on how to operate the medicament device correctly, such that theaccuracy of an emitted dosage is improved. The methods and devicesdescribed herein may allow a user to operate different medicamentdevices comprising different recommended parameters (e.g., shakeparameters, inhalation parameters, etc) appropriately using a singlesensor device, as the sensor devices described herein may be tailored tospecific types of medicament devices, e.g., via an adapter. In oneaspect, a device may comprise one or more sensors for detecting one ormore usage parameters of a medicament device.

In one particular aspect, a sensor device is provided for guiding usageof a medicament device, the sensor device comprising: (a) a coupler forcoupling to the medicament device, wherein the medicament device isselected from a plurality of different types of medicament devices; (b)one or more sensors for detecting use of the medicament device; (c) aprocessor configured to: (i) automatically process one or moreparameters associated with the medicament device; and (ii) output ansignal based on the one or more parameters; and (d) an indicatorconfigured to: (i) operably receive the signal; and (ii) output aguidance to a user of the medicament device, wherein the guidance variesdepending on a type of medicament device that is selected.

In another particular aspect, a kit is provided comprising: a sensordevice as described herein, and instructions for coupling and/ordecoupling the sensor device to an adapter comprising a memory storingthe one or more parameters associated with the medicament device.

In another aspect, an adapter is provided for guiding usage of amedicament device, the adapter comprising: (a) a first coupler forcoupling to the medicament device; (b) a memory storing one or moreparameters associated with the medicament device; and (c) a secondcoupler for coupling to a sensor device, wherein the sensor device isconfigured to output a guidance to a user of the medicament device.

In a further aspect, a kit is provided comprising: an adapter asdescribed herein; and instructions for coupling and/or decoupling theadapter to a medicament device selected from a plurality of differenttypes of medicament devices.

In another aspect, a method is provided of a using a sensor deviceconfigured to couple to a plurality of different types of medicamentdevices, the method comprising: (a) coupling the sensor device to afirst medicament device; (b) processing one or more parametersassociated with the first medicament device; (c) guiding usage of thefirst medicament device based on the processed one or more parametersassociated with the first medicament device; (d) decoupling the sensordevice from the first medicament device; (e) coupling the sensor deviceto a second medicament device, wherein the second medicament devicediffers in a type of medicament device from the first medicament device;(f) processing one or more parameters associated with the secondmedicament device; and (g) guiding usage of the second medicament devicebased on the processed one or more parameters associated with the secondmedicament device, wherein guiding usage of the second medicament devicediffers from guiding usage of the first medicament device.

In yet another aspect, a method is provided for measuring usage of aninhaler using one or more sensors, the method comprising: with aid ofthe one or more sensors: (a) measuring a duration of shaking theinhaler; (b) measuring a duration of a time subsequent to the shaking;(c) measuring an inhalation of a user using inhaler; (d) measuring anactuation of the inhaler; and (e) measuring a duration of a hold downtime of the actuation.

In another aspect, a device is provided for monitoring usage of amedicament device, the device comprising: (a) an adapter, wherein theadapter comprises a memory storing a set of parameters specific to atype of the medicament device; and (b) a sensor device separable from,and in operable communication with the adapter, wherein the sensordevice is configured to be used with a plurality of different types ofadapters each comprising a unique set of parameters specific todifferent types of medicament devices, wherein the sensor device isconfigured to produce an output based on the set of parameters.

In another aspect, a method is provided for using an inhaler or nasaldevice with aid of a sensor, the method comprising: (a) shaking saidinhaler or nasal device; (b) measuring a shake-to-fire interval foractuating the inhaler or nasal device using the sensor; and (c)actuating the inhaler or nasal device when said sensor produces anoutput, wherein when said sensor detects an end of said shake-to-fireinterval, said sensor produces said output.

In yet another aspect, a method is provided for using an inhaler ornasal device with aid of a sensor, the method comprising: (a)compressing said inhaler or nasal device for a period of time, whereinsaid period of time comprises an actuation hold time window; and (b)decompressing said inhaler or nasal device when said sensor produces anoutput, wherein when said sensor detects an end of said actuation holdtime window, said sensor produces said output.

In another aspect, a device is provided for monitoring usage of amedicament device comprising: (a) an adapter comprising: (i) a distalend comprising a first adapter coupler for coupling to the medicamentdevice; (ii) a memory storing one or more parameters associated with themedicament device; (iii) a proximal end comprising a second adaptercoupler for coupling to a sensor device, wherein the second adaptercoupler comprises a protrusion comprising an electrical interface; and(iv) a pressure tap tube, wherein the pressure tap tube comprises afirst end on the proximal end side of the adapter and a second endlocated distally away from the distal end side of the adapter; and (b) asensor device removably coupled to the adapter, wherein the sensordevice comprises: (i) a mating surface for mating with the proximal endof the adapter, comprising: a receiving port comprising an electricalinterface, wherein the receiving port is complementary to the protrusionand is configured to receive the protrusion; and an opening configuredto receive the first end of the pressure tap tube; (ii) a pressuresensing cavity operably coupled to the opening, the pressure sensingcavity defining an enclosed chamber with the opening and comprising abarometer; (iii) a processor operably coupled to the receiving port, theprocessor configured to: receive the one or more parameters associatedwith the medicament device from the adapter; automatically process theone or more parameters associated with the medicament device; and outputa signal based on the one or more parameters; and (iv) an indicatorconfigured to: operably receive the signal; and output a guidance to auser of the medicament device, wherein the guidance varies depending onthe one or more parameters that is received.

In some cases, the methods and devices described herein may be used withessentially any medicament device. In particular cases, the methods anddevices described herein may be used with an inhaler device. An inhalerdevice may be utilized for e.g., delivery of a drug or substancedirectly to the lungs of a subject. The methods and devices describedherein may be suitable for use with any inhaler device that requiresshaking and/or actuation. In some cases, the inhaler device is ametered-dose inhaler (MDI), for example, a pressurized metered-doseinhaler (pMDI). Non-limiting examples of MDIs may include AeroChamber®and Autohaler®. In some cases, the MDI comprises a spacer or aerosolholding chamber. The inhaler device may be a dry powder inhaler,non-limiting examples including: Aerolizer®, Diskus®, Ellipta™,Flexhaler®, Handihaler®, Neohaler®, Pressair™, Twisthaler®, Rotahaler®and Turbuhaler®.

In other particular instances, the methods and devices may be used witha nasal device for, e.g., local delivery of a drug to the nose or theparanasal sinuses. Non-limiting examples of nasal devices may include:mechanical spray pumps (e.g., squeeze bottles, multi-dose metered-dosespray pumps, single/duo-dose spray pumps, bi-directional multi-dosespray pumps), gas-driven spray systems/atomizers, mechanical powdersprayers, breath actuated inhalers, and insufflators. In otherparticular instances, the methods and devices may be used with anebulizer and/or other devices.

The inhaler or nasal device may be an Orally Inhaled and Nasal DrugProduct (OINDP). Non-limiting examples of OINDPs which may be suitablefor use with the devices described herein may include: aclidiniumbromide inhalation powder (Tudorza® Pressair®), ipratropium inhalationaerosol (Atrovent® HFA), tiotropium inhalation powder Spiriva®Handihaler®), tiotropium inhalation solution (Spiriva® Respimat®),umeclidinium inhalation powder (Incruse® Ellipta®),albuterol/ipratropium inhalation solution (DuoNeb®),albuterol/ipratropium bromide inhalation spray (Combivent® Respimat®),budesonide/formoterol fumarate dihydrate inhalation aerosol(Symbicort®), fluticasone/salmeterol inhalation powder (Advair®Diskus®), fluticasone/salmeterol inhalation aerosol (Advair® HFA),fluticasone furoate/vilanterol inhalation powder (Breo® Ellipta®),mometasone furoate/formoterol fumarate inhalation aerosol (Dulera®),tiotropium bromide/olodaterol inhalation spray (Stiolto™ Respimat®),umeclidinium/vilanterol inhalation powder (Anoro® Ellipta®),beclomethasone dipropionate HFA inhalation aerosol (Qvar®),beclomethasone dipropionate nasal aerosol (QNASL®), budesonideinhalation powder (Pulmicort® Flexhaler®), budesonide inhalationsuspension (Pulmicort® Respules®), ciclesonide inhalation aerosol(Alvesco®), flunisolide inhalation aerosol (Aerospan®), fluticasonefuroate inhalation powder (Arnuity™ Ellipta®), fluticasone propionateinhalation aerosol (Flovent® HFA), fluticasone propionate inhalationpowder (Flovent® Diskus®), mometasone furoate inhalation powder(Asmanex® Twisthaler®), mometasone furoate inhalation aerosol (Asmanex®HFA), arformoterol tartrate inhalation solution (Brovana®), formoterolfumarate inhalation powder (Foradil®), formoterol fumarate inhalationsolution (Perforomist®), indacaterol inhalation powder (Arcapta™Neohaler™), olodaterol inhalation spray (Striverdi® Respimat®),salmeterol xinafoate inhalation powder (Serevent® Diskus®), albuterolsulfate inhalation powder (Proair® Respiclick®), albuterol sulfateinhalation aerosol (Proair® HFA), albuterol inhalation solution(AccuNeb®), albuterol sulfate inhalation aerosol (Proventil® HFA),albuterol sulfate inhalation aerosol (Ventolin® HFA), levalbuteroltartrate inhalation aerosol (Xopenex® HFA), and ciclesonide nasalaerosol (Zetonna®).

The medicament device may include a formulation of, for example, a drugor an active ingredient. In some cases, the formulation includes one ormore excipients. In some cases, the formulation does not include anyexcipients. In some cases, the formulation includes one or morepropellants. The formulation may be a suspension, a solution, or a drypowder.

The methods and devices described herein may involve one or moresensors. The one or more sensors may be in contact with the medicamentdevice. In some cases, the one or more sensors are in direct contactwith the medicament device, for example, one or more sensor componentsis directly contacting or touching a component of the medicament device.The one or more sensors may be in contact with any part of themedicament device, such as, for example, the housing of the medicamentdevice or the canister of the medicament device. In some cases, the oneor more sensors are in contact with the housing of the medicamentdevice. The housing of the medicament device may be the plasticcomponent of the medicament device such as the actuator, the mouthpiece,or both. In some cases, the one or more sensors are in contact with thecanister of the medicament device. The canister may be the metalcomponent of the medicament device (e.g., stainless steel or aluminum)which contains the formulation. In such cases where the medicamentdevice is a metered dose inhaler, the one or more sensors may be incontact with the metering valve.

In some cases, the one or more sensors may be affixed to the holder orthe canister of the medicament device. In such cases where themedicament device is an inhaler device, the one or more sensors may beaffixed to the actuator and/or mouthpiece of the inhaler device. In suchcases where the medicament device is a nasal device, the one or moresensors may be affixed to the nasal device's bottle, pump, or actuatornozzle tip. In some cases, the one or more sensors are permanentlyaffixed or attached to the holder or the canister of the medicamentdevice. For example, the one or more sensors may not be detachable ordecoupled from the medicament device. The one or more sensors may beglued, welded, embedded, adhered, or otherwise affixed to the medicamentdevice in such a way that the one or more sensors cannot be removed. Inother cases, the one or more sensors may be removably affixed to theholder or canister of the medicament device. In this example, the one ormore sensors may be capable of being removed from the holder or thecanister of the medicament device. In some instances, the one or moresensors may be removed from one medicament device and affixed to aseparate medicament device. In some instances, the one or more sensorsmay be attached to an adapter that provides for removably affixing thesensor to a medicament device. In some cases, the medicament device maybe provided and/or obtained with the one or more sensors alreadyattached. In other cases, the medicament device may be provided and/orobtained without the one or more sensors already attached. In particularcases, the one or more sensors may be sold and/or purchased separatelyfrom the medicament device. In such cases, the one or more sensors maybe attached to the medicament device by, for example, the user (e.g., apatient), a healthcare provider, or a manufacturer.

In some instances, the one or more sensors are contained within a sensordevice or sensor package configured to be attached to a medicamentdevice. The sensor device may comprise a housing for containing the oneor more sensors. The sensor device may further comprise, containedwithin the housing, the one or more sensors. The one or more sensors mayinclude any type of sensor that may be useful for monitoring usage of amedicament device. Non-limiting examples of sensors that may be providedin the sensor device include: airflow sensors (e.g., a thermistor, apressure sensor, a barometer), integrated flow sensors, position ordisplacement sensors, rate sensors, tilt sensors, touch sensors (e.g.,an electrode, a capacitive or resistive touch sensor), shake sensors(e.g., accelerometer), magnetometers, temperature sensors, globalpositioning system (GPS) chips, ambient light sensors, sensors capableof detecting more than one parameter, and any combination thereof.

In some cases, the sensor device may be used with essentially anymedicament device. In particular instances, the sensor device may beuniversally configured such that said sensor device is operable with anynumber and variety of medicament devices. In a particular aspect, thesensor device may be coupled to and used with a first medicament device,then subsequently decoupled from the medicament device and then attachedto and used with a second, different medicament device. The first andsecond medicament devices may be of the same type, or different types. Atype of medicament device as referred to herein, may depend onspecifications of the medicament device. For example, a type may dependon active ingredients, inactive ingredients, strength, recommended shakeduration, and such as shown in the columns of FIG. 9. In some instances,the sensor device may be reused a plurality of times, for example, 2, 3,4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50, 100, 200, 500, 1000, 2000,5000, or more times.

In some cases, the sensor device may be coupled directly to a medicamentdevice (e.g., by a coupler that allows for attachment to the medicamentdevice) or by attachment to an adapter. For example, the sensor devicemay comprise a communication unit (e.g., wireless communication unit,RFID chip, optical reader, etc). A medicament device (e.g., canisterused with an inhaler) may comprise another communication unit (e.g.,wireless communication unit, RFIC chip, barcode that may be read, etc)which can communicate with the communication unit of the sensor device.In such a case, the medicament device may be configured to communicaterelevant parameters (e.g., shake parameters, etc) that can be processedby the sensor device to guide a user to appropriately use the medicamentdevice.

In some instances, the sensor device may be coupled to a medicamentdevice via one or more intermediary devices. For example, the sensordevice may be coupled to the medicament device via an adapter. Theadapter may be configured to couple directly to a medicament device or acomponent thereof. In one such example, the adapter may be specific fora particular medicament device such that the universal sensor device maybe coupled to virtually any medicament device by use of theproduct-specific adapter. The sensor device may include a coupler forcoupling to the medicament device and/or the adapter. The coupler mayinclude a receiving port for receiving a complementary protrusion of theadapter. In such cases, the coupler may also include an electricalinterface for electrically coupling to the adapter. In some cases, thecoupler may include one or more latch points for receiving one or morelatches of an adapter comprising an adhesive configured to couple to themedicament device.

FIGS. 1A-C depict a non-limiting example of how a sensor device coupledto an adapter is attached to a medicament device in accordance with thedisclosure. FIG. 1A depicts a sensor device 101 coupled to an adapter103. In some cases, the sensor device 101 may be attached to themedicament device 105 by attaching 107 the adapter 103 (with the sensordevice 101 attached) to the holder or canister of the inhaler device105, as shown in FIGS. 1B & 1C.

In some instances, the adapter may be designed to fit onto the holder orcanister of a specific medicament device product. In some instances, thesensor device 201 may be affixed 205 e.g., snapped or sealed, onto theadapter 203 as depicted in FIG. 2A. The sensor device (i.e., the sensordevice and the adapter) may then be affixed to the inhaler device asdescribed above. In some cases, the sensor device and product-specificadapter may be provided separately or as a unit or kit containing one ormore sensor devices and one or more adapters. For example, as shown inFIG. 2B, a sensor device 201 may be provided with one or moreproduct-specific adapters 201 a, 201 b, 201 c that may be attached tothe sensor device as described previously.

In some cases, the sensor device may be reusable, for example, thesensor device may be configured to be used 2, 3, 4, 5, 6, 7, 8, 9, 10,15, 20, 30, 40, 50, 100, 200, 500, 1000, 2000, 4000, or more times.Optionally, the sensor device may be configured to be used indefinitely.The sensor device may be configured to be used for a duration of atleast 1 month, 2 months, 4 months, 6 months, 8 months, 10 months, 12months, or more. The sensor device may be rechargeable, for example, thesensor device may comprise a battery that can be recharged one or moretimes. In some cases, the battery may be recharged at least 1, 2, 3, 4,5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50, or more times. In some instances,the battery may be removed from the sensor device and recharged. In somecases, the battery may be replaced at least 1, 2, 3, 4, 5, 6, 7, 8, 9,10, 15, 20, 30, 40, 50, or more times.

In some cases, the adapter may be disposable. In some instances, theadapter may be configured to be used with a single medicament deviceproduct. In some instances, the adapter may be used through the life ofthe medicament device, after which the adapter may be discarded. Thereusability of the sensor device may beneficially allow a user to use asingle sensor device with a plurality of different adapters depending onthe user's needs. In some instances, a single user having differentproduct needs may use a single sensor device with a plurality ofdifferent adapters. For example, a sensor device may be used inconjunction with a first adapter capable of being used with a firstmedicament device for the life of the first medicament device. After thefirst medicament device has been exhausted, the user may remove theadapter and sensor device from the first medicament device, discard thefirst adapter, and then use the same sensor device with a second adaptercapable of being used with a second medicament device for the life ofthe second medicament device. In some cases, the first and secondmedicament devices are the same type (e.g., the same medicamentproduct), and may utilize the same type of adapter (i.e., an adapterthat is capable of being used with either the first or the secondmedicament device). In other cases, the first and second medicamentdevices are different, and may utilize different types of adapters(i.e., the first adapter is capable of being used with the firstmedicament device, but not the second medicament device; and the secondadapter is capable of being used with the second medicament device, butnot the first medicament device). In both scenarios, the sensor devicemay be configured to work in conjunction with both adapters, such thatthe sensor device can be re-used with different adapters.

The sensor device may further include additional working components. Forexample, the sensor device may include a processor configured toautomatically process one or more parameters associated with themedicament device; and output a signal based on the one or moreparameters. In some cases, the sensor device may include amicrocontroller which may be used to manage and control the systemfunctions including, but not limited to, firmware logic and dataprocessing algorithms, timers for providing a precision time base forsensor data acquisition functions, and audio feedback sequences. Thesensor device may include an audio player, amplifier, and/or loudspeakerfor providing auditory feedback to a user of the medicament device. Thesensor device may include a battery, such as a rechargeablelithium-based battery. Such battery may be capable of powering thesensor device for up to 60 days before a recharge. The sensor device mayinclude an LED for indicating battery charging status and PC applicationconnectivity. The sensor device may include a fixed amount ofnon-volatile memory for storing usage history data and other systemsettings. The sensor device may include a real-time clock for providingaccurate date and time-stamping of the entries in the usage history. Thereal-time clock may be capable of providing accurate timekeeping evenwhen connected to a fully discharged battery. The sensor device mayinclude a button switch to turn the system on or off. The button switchmay be located anywhere on the sensor device, and in some cases, islocated on a distal end of the sensor device. The button switch may betouched, pushed, or otherwise contacted by a user of the medicamentdevice. The button switch may perform additional features such as, forexample, enabling a user to acknowledge feedback received from thesensor device or for directing system operation. The sensor device mayalso include a USB connector interface that can be used to recharge thebattery or communicate with the PC application software and/or wirelessinterface compatibility such as Bluetooth® capabilities. In such caseswhere the sensor device is used in conjunction with an adapter, thesensor device may include an electro-mechanical interface for connectingto the adapter.

FIG. 3A illustrates an exploded view of a sensor device from the top, inaccordance with embodiments. FIG. 3C illustrates a perspective view of asensor device 300 from the top, in accordance with embodiments. Thesensor device may comprise an upper body 302 and a lower body 304. Eachof the upper body 302 and the lower body 304 may or may not be circular.Each of the upper body 302 and the lower body 304 may or may not besubstantially flat. In some instances, the upper 302 or lower body 304may comprise interactive components. For example, a surface 306 of theupper body 302 may comprise a movable component. The movable componentmay be actuatable by a user. The movable component may be used tocontrol a functionality of the sensor device 300, e.g., to turn thesensor device on or off, or change an operating mode of the sensordevice 300. As another example, a surface 306 of the upper body 302 maycomprise a visual display. The visual display may be used to give anindication, or guidance to a user, as described herein. As anotherexample, a surface 306 of the upper body 302 may comprise a touchsensitive button. The touch sensitive button may be used to control afunctionality of the sensor device 300, e.g., to turn the sensor deviceon or off, or change an operating mode of the sensor device 300.Optionally, the touch sensitive button may be configured to functionalso as a visual display as described above. While the interactivecomponent of the sensor device 300 is illustrated on a top surface ofthe upper body as an example, it is to be understood that it may belocated anywhere, e.g., on a side, on the lower body, etc. The lowerbody 304 may comprise a sound chamber 316. The sound chamber may aid intransmission of auditory indications generated from the sensor device300. In some instances, the lower body 304 may comprise sound ports 318which may allow auditory instructions to be communicated to a user usingthe sensor device 300.

The upper body 302 and the lower body 304 may comprise a housing, orexterior of the sensor device 300. The housing may comprise a volumeequal to or less than 4 cm³, 6 cm³, 8 cm³, 10 cm³, 12 cm³, 14 cm³, 16cm³, 18 cm³, 20 cm³, 25 cm³, 30 cm³, 35 cm³, 40 cm³, 50 cm³, or anyvalue there in-between. The small size of the housing may ensure thatthe sensor device 300 remains unobtrusive to a user of the sensor device300. The upper body 302 and the lower body 304 may be configured to bepermanently coupled to one another. Alternatively, the upper 302 andlower body 304 may be configured to be removably coupled to one anothersuch that a user may remove the upper body 302 from the lower body 304or vice versa.

In some instances, the upper body 302 and the lower body 304 maysurround or enclose electronic components 310. The upper body 302 andthe lower body 304 may partially, or wholly, surround or enclose theelectronic components 310. The electronic components 310 of the sensordevice 300 may comprise one or more circuit boards 311, batteries 312,interfaces 314, or other elements 308. The electronic components 310 ofthe sensor device 300 may comprise a speaker, one or more processors,one or more additional sensors, etc as further described elsewhere. Thecircuit boards 310 may be rigid and/or flexible. The circuit boards 310may comprise two rigid components coupled together by a flexiblecomponent. In some instances, the two rigid components may sandwichthere between one or more batteries 312. Advantageously, thisconfiguration may allow a barometer 320 to be operably coupled to apressure tap tube 410 as further described elsewhere while allowing aninteractive component of the sensor device 300 (e.g., a switch 306) tobe located on a top portion of the device 300. The circuit board 310 mayenable various other electronic components to couple to one anotherand/or communicate with one another. The batteries 312 may provide apower source for the sensor device 300. The batteries 312 may allow thesensor device 300 to run for a period of time equal to or more thanabout 1 hour, 2 hours, 5 hours, 10 hours, 16 hours, 24 hours, 2 days, 5days, a week, 2 weeks, 4 weeks, a month, 2 months, 4 months, 6 months, 8months, 1 year, 2 years, or more years. Optionally, the batteries 312may be rechargeable. The interfaces 314 may allow the sensor device 300to communicate with one or more external devices. In some instances, theinterface may be a USB port 314. In some instances, the sensor device isconfigured for wireless interface compatibility (e.g., Bluetooth®).Optionally, the interfaces 314 may allow the recharging of the batteries312 of the sensor device 300. The other elements 308 may comprisevarious additional elements. In some instances, the other elements 308may comprise a button, or a switch. The switch may be used to control afunctionality of the sensor device 300, e.g., to turn the sensor device300 on or off, or change an operating mode of the sensor device 300. Forexample, a user actuating a surface 306 of the sensor device 300 maypress on the button 308, affecting the sensor device 300 (e.g., turningit on or off).

The other elements in some instances may comprise sensors, such as anaccelerometer, a barometer 320, a temperature sensor, a magnetometer, anambient light sensor, or a global positioning system (GPS). Theaccelerometer may allow the sensing device to measure various parametersdescribed throughout such as the shake parameters, and/or orientation ofthe medicament device. In some instances, the accelerometer may belocated on the sensor device 300 such that when the sensor device iscoupled to the medicament device, it is located along a central axis ofthe medicament device, as depicted, for example, in FIG. 11. Thebarometer 320 may allow the sensor device to measure various parametersdescribed throughout such as the inhalation parameters. The temperaturesensor may allow the sensor device to measure various parametersdescribed throughout such as a temperature of the environment around thesensor device and/or the medicament device. This may advantageouslyallow the sensor device to adjust guidance for using the medicamentdevice, or inhaler, e.g., by varying the guidance depending onenvironmental factors. As one example, if it is determined that themedicament device is being used in a very cold environment, the sensordevice may adjust its guidance to (e.g., shake parameters) or evenrecommend the user from refraining from using the medicament deviceuntil a predetermined temperature is reached. The predeterminedtemperature may be equal to or less than about 0° C., 2° C., 4° C., 6°C., 8° C., 10° C., 12° C., 14° C., 16° C., 18° C., 20° C., 22° C., 24°C., 26° C., 28° C., 30° C., 32° C., 34° C., 36° C., 38° C., or 40° C.The magnetometer may allow the sensor device to measure variousparameters described throughout such as a true direction of the sensordevice and/or the medicament device. This may advantageously allow thesensor device to adjust guidance for using the medicament device, orinhaler, e.g., by varying the guidance depending on environmentalfactors. As one example, if it is determined that a person would havebeen facing in the direction of sunlight, the sensor device may adjustits guidance from a visual (e.g., light) based guidance to an auditorybased guidance. The ambient light sensor may allow the sensor device tomeasure the ambient light level of the environment where the sensordevice is being used and adjust its indication settings automatically(e.g., increase/decrease the visual indicator brightness level). The GPSmay allow the sensor device to measure various parameters describedthroughout, such as a global coordinate of where the sensor device isbeing used, etc. This may advantageously allow the sensor device toadjust guidance for using the medicament device, or inhaler, e.g., byvarying the guidance depending on environmental factors such as anelevation, humidity, etc of where the device is being used in.

FIG. 3B illustrates a blown up view of a sensor device 300 from thebottom, in accordance with embodiments. FIG. 3D illustrates aperspective view of a sensor device 300 from the bottom, in accordancewith embodiments. The sensor device 300 may be the sensor device 300 asdescribed throughout, e.g., as shown in FIG. 3A. A lower body 304 of thesensor device 300 may comprise one or more couplers 328, 330.Optionally, the lower body 304 of the sensor device 300 together withthe electronic components may comprise one or more couplers. The one ormore couplers may be configured to couple to a medicament device, e.g.directly or indirectly via other intermediary devices. While couplers inthe form of a receiving port 328, 330 are illustrated in FIG. 3B, it isto be understood that any form of coupling (e.g., adhesives,protrusions, form fitting mechanism, hooks, etc.) may be an example of acoupler. The one or more couplers may comprise a receiving port 328,330. In some instances, the one or more couplers, or the one or morereceiving ports 328, 330 may comprise, or lead to an electricalinterface 324. The electrical interface 324 may be electrical contacts.In some instances, the electrical interface 324 may allow the sensordevice 300 to communicate (e.g., electrically) with other devices, suchas an adapter 400 described herein. Optionally, the receiving port 328,330 may be configured (e.g., shaped) to removably receive acomplementary protrusion of an adapter 408 described herein. Optionally,the receiving port 328, 330 may be configured to allow communicationwith an adapter 400 described herein, which may comprise a memorystoring one or more parameters associated with a medicament device. Insome instances, the one or more couplers may comprise one or more latchpoints 328. The latch points 328 may allow for secure form fitting ofthe sensor device 300 with one or more other devices, such as themedicament device and/or adapters 400 described herein. The one or morelatch points 328 may be configured for receiving one or more latches 402of other devices, such as the medicament device and/or adapters 400.Advantageously, the one or more latch points 328 which comprise agreater integrity (e.g., in structure) may allow the sensor device 300to be used over long periods of time without failing, while other moredisposable components such as the adapter 400 are used for shorterperiods of time (e.g., with the protrusions).

The lower body 304 of the sensor device 300 may comprise an opening 326.The opening 326 may also be referred to herein as an interface to apressure tap. The opening 326 may be configured to receive a pressuretap tube 410 of the adapter 400. The opening 326 may lead to a sensor,such as a barometer 320, and/or a pressure sensing cavity (see, e.g.,FIG. 7). Optionally, the opening 326 may be a single opening (e.g., theonly opening) to the pressure sensing cavity. Accordingly, the pressuresensing cavity may be isolated (e.g., except for the opening). FIG. 7illustrates a pressure sensing cavity 320 coupled to a pressure tap tube410 of an adapter 400, in accordance with embodiments. As describedthroughout, the pressure tap tube 410 may comprise a proximal portion702 located on a first surface (e.g., top surface) of the adapter 400.The proximal portion 702 may comprise a sealing element 704. The sealingelement in some instances may be an “0” ring. The pressure sensingcavity may comprise one or more sensors, such as the barometer 320. Thepressure sensing cavity may be minimally sized so as to allow thebarometer 320 to sense a pressure change due to a user's inhalation assoon as possible. In some instances, the pressure sensing cavity maycomprise a size equal to or less than about 2 cm³, 4 cm³, 6 mm³, 8 mm³,10 mm³, 12 mm³, 14 mm³, 16 mm³, 20 mm³, 22 mm³, 24 mm³, 26 mm³, 28 mm³,30 cm³, or any value there between. The pressure sensing cavity in someinstances may allow a bidirectional flow of air in and out of thepressure sensing cavity, e.g., through the opening. Each of the pressuresensing cavity and/or the barometer 320 may be located, or positioned ona circuit board 310 described above. While the barometer 320 isillustrated located hanging from a ceiling or an underside of thecircuit board, it is to be understood that the configuration isillustrative and not limiting. FIG. 8 illustrates a pressure sensingcavity with a barometer located on a bottom surface of a circuit board,in accordance with embodiments. As shown, the barometer, or a sensingarea of the barometer may be exposed on a silicon substrate itself.

Referring back to FIG. 3, the electronic components 310 may comprise anindicator. The indicator may comprise a speaker, a light source (e.g., alight emitting diode), or a visual display as referred to above. Theindicator may be configured to operably receive a signal generated,processed, or output from a processor. In some instances, the indicatormay be configured to output a guidance to a user of the medicamentdevice described herein, e.g., via visual or auditory indications. Insuch cases where an auditory indicator is used, the auditory indicatormay be adjustable or customizable by the user. For example, the volumemay be adjusted or the style of voice or sound may be changed orcustomized. Similarly, when a visual indicator is used, the color oflight, the pattern of light indications, and/or the brightness of thelight may be adjusted. In some cases, the user may have the ability tochange the device from an auditory indication to a visual indication andvice versa. In some instances, the guidance may vary depending on a typeof medicament device that is selected, or being used. The type ofmedicament device that is being used may depend on the target indicationfor the device, shot rating, active ingredients, inactive ingredients,strength, propellants, recommended time between actuations, canistercontent weight, shot weight, formulation type, recommended number ofpriming steps, recommended duration between timing, recommended numberof re-priming steps, or recommended shake duration, e.g., as shown inFIG. 9. In some instances, the guidance may be tailored such that thesensor gives a guidance according to the recommended parameters. In someinstances, depending on the type of the medicament device, the guidancemay vary in a duration of shaking a medicament device, a shake-to-fireinterval, a wait time between actuations, a number of priming steps, anumber of re-priming steps, or a duration until re-priming steps. Insome instances, the duration of shaking the medicament device may varybetween 0 and 30 seconds. In some instances, the wait time betweenactuations varies between 0 to 60 seconds. In some instances, the numberof priming steps varies between 0 and 5. In some instances, the numberof re-priming steps varies between 0 and 5. In some instances, theduration until re-priming steps varies between 0 and 30 days. In someinstances, the shake-to-fire interval varies from 0 to 30 seconds.

The sensor device 300 may comprise one or more processors, or amicrocontroller 322. The processor may be configured to automaticallyprocess one or more parameters associated with the medicament device.The one or more parameters may be recommended parameters for themedicament device (e.g., recommended shake parameters) for example, asshown in FIG. 9. In some instances, the processor may be configured toreceive the one or more parameters from another device such as theadapter 400 referred to herein. For example, once the sensor device isconnected to the adapter (as depicted in FIGS. 5A-B and FIGS. 6A-B)(e.g., and turned on and/or authenticated), the sensor device 300 may beconfigured to automatically receive the one or more parametersassociated with the medicament device from the adapter 400. Accordingly,the sensor device may be configured to be utilized with a plurality ofdifferent medicament devices and output an appropriate guidanceaccording to the type of the medicament device. The processor, may beconfigured to output a signal based on the processed one or moreprocessors. In some instances, the sensor device may be configured togive different guidance depending on the type of medicament device. Insome instances, the sensor device may be configured to give a guidancediffering in 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more parameters (e.g.,shake parameter) depending on the type of medicament device (or adapter)it is coupled to. As described throughout, the medicament device mayindividually or collectively also refer to a canister or an inhaler. Theinhaler may be a pressurized dose metered inhaler. Optionally, a kit maybe provided. The kit may comprise the sensor device describedthroughout, and instructions for coupling and/or decoupling the sensordevice to an adapter. Alternatively, the kit may comprise the sensordevice described throughout, the adapter device described throughout,and instructions for coupling and/or decoupling the sensor device to anadapter.

In some embodiments, the adapter comprises electronics and/or workingcomponents. In some cases, the adapter is programmed withproduct-specific operating parameters (PSOPs), for example, theoperating parameters for using a specific medicament device correctly.For example, the adapter may be programmed with specific shakeparameters, actuation parameters, and the like, that are specific for amedicament device. PSOPs may be provided by the manufacturer of amedicament device (e.g., on an instruction sheet) or may be determinedempirically. FIG. 9 depicts non-limiting examples of PSOPs for specificmedicament devices that may be programmed into an adapter for use withsuch devices. When used in conjunction with the sensor device, theadapter may receive data from the sensor device, including, but notlimited to, actuation date and/or time, shot number (corresponding tothe number of times the device has been actuated), and sensor ID. Theadapter, programmed with the PSOPs, may determine when one or morepredetermined thresholds of shake parameters, actuation parameters,etc., has/have been reached. The adapter may then relay a signal to thesensor device, and a light or auditory or other indicator may beactivated in the sensor device as further described herein. The adaptermay include a cryptographic authenticating device for uniquelyidentifying the adapter and for preventing cloning or counterfeiting ofthe adapter. The adapter may further include a secure memory block forstoring the PSOPs for reading exclusively by the adapter aftersuccessful authentication by the authenticating device.

FIGS. 4A-C depict a non-limiting example of a product-specific adapter400 as envisioned herein that may be used in conjunction with a sensordevice 300 for coupling to a medicament device, such as one depicted inFIG. 3. The product-specific adapter 400 may include one or more latches402 to allow for coupling to a sensor device 300 as described herein.The one or more latches 402 may be, for example, protrusions on the baseof the adapter 400 that are complementary to one or more receiving ports328 on a sensor device 300. The one or more latches 402 may be insertedinto the complementary receiving ports 328 of the sensor device 300allowing the adapter 400 to be affixed to the sensor device 300. The oneor more latches 402 may allow for removable coupling of the adapter 400with the sensor device 300. The adapter 400 may further include ahollow, non-intrusive pressure tap tube 410 for providing access to theair flowing in between the inhaler canister 401 and actuator body 403during inhalation. The pressure tap tube may be hollow. In someinstances, the pressure tap tube may be configured to be located on aside of the adapter and/or the sensor device. The pressure tap tube maybe configured to run alongside, or be parallel to the medicament device.The pressure tap tube may be configured to be located towards amouthpiece of a medicament device, or inhaler such that inhalation of auser can affect air within the pressure tap tube. The pressure tap tubemay include one or more pressure tap ports 412. The pressure tap portsmay allow inflow or outflow of air through the pressure tap tube, whichmay be sensed by a pressure sensor (e.g., located on a sensor device).The pressure tap ports may be located on a side of the pressure tap tubeto allow sensing of pressure of the moving air going across the pressuretap tube. The pressure tap tube 410 may be configured such that it matesto the sensor device 300 by way of a mating surface 404 and provides asealed interface to the sensor device's barometer 320 so that the systemcan accurately detect inhalation. In such cases, the barometer signalmay be directly related to the user's inhalation. The pressure tab tube410 may be positioned into the gap between the inhaler canister 401 andthe actuator 403. The adapter 400 may additionally include acryptographic authenticating device 406 for uniquely identifying theadapter 400 and for preventing cloning or counterfeiting of the adapter400. The adapter 400 may further include a secure memory block forstoring the PSOPs for reading exclusively by the adapter aftersuccessful authentication by the authenticating device 406. The adapter400 may further include an electro-mechanical coupler 408 that allowsthe adapter 400 to be electronically connected to the sensor device 300for receiving data from, and/or transmitting data to the one or moresensors and for relaying an output to the indicators on the sensordevice 300. For example, the adapter may be configured to transmit oneor more parameters described herein to the sensor device. In someinstances, the adapter may automatically transmit one or more parametersstored on a memory relating to a medicament device when electricalconnection is established between the sensor device and the adapter.Optionally, the adapter may transmit one or more parameters stored on amemory relating to a medicament device when the sensor device and/oradapter is authenticated. FIG. 4B depicts an adapter 400 coupled to aninhaler device. FIG. 4C depicts an expanded view of a distal end of thepressure tap tube 410 comprising pressure tap ports 412 and a pressuretap cap 414.

In one example, the sensor device may be product-agnostic (i.e., nottailored to a specific medicament device). The sensor device may be usedin conjunction with a plurality of product-specific adapters eachcomprising different PSOPs, or with a plurality of product-specificadapters, each comprising the same PSOPs. In this example, the sensordevice may be removably attached to a disposable adapter, and then theadapter may be attached to the specific medicament device.Alternatively, in this example, the sensor device may be removablyattached to a disposable adapter that is already attached to thespecific medicament device. After the medicament device has beenexhausted, the sensor device may be removed from the adapter, theproduct-specific adapter may be disposed along with the empty medicamentdevice, and the sensor device may be attached to a differentproduct-specific adapter. In one non-limiting example, a user maypurchase a set or kit comprising one or more sensor devices and aplurality of product-specific adapters, each product-specific adaptercomprising PSOPs for a specific medicament device. During normal usageor after the user has exhausted the drug product, the user may disposeof the medicament device and the adapter, and attach the sensor deviceto a new adapter and medicament device. In this way, the sensor devicecan be reused a plurality of times.

The sensor device may be affixed to any component of the medicamentdevice, and generally, the sensor device will be affixed such that theone or more sensors contained within the sensor device are capable ofsensing or detecting one or more parameters of the medicament device.For example, a sensor device may be affixed to the holder of themedicament device to detect, for example, shake frequency of themedicament device. In another example, a sensor device may be affixed tothe canister of the medicament device to detect, for example, shakeangle (of the canister relative to its vertical axis). The sensor devicemay be affixed such that the sensor device does not impede thefunctionality of the medicament device. In some cases, the sensor deviceis affixed to a surface of the holder or the canister of the medicamentdevice. The surface may be on the outside or the inside of the holder orthe canister. In some cases, the sensor device may be embedded into theholder or the canister of the medicament device, for example, into aplastic or metal component of the medicament device. A portion of thesensor device or the entirety of the sensor device may be embedded intothe holder or the canister of the medicament device. FIG. 10 depicts amedicament device 1000 demonstrating three non-limiting examples ofpositioning of the sensor device on the medicament device. The sensordevice may be affixed to the medicament (e.g., with an adhesive strip,or by way of a product-specific adapter) 1001, 1003, 1005. The sensordevice may be operably coupled to an indicator or signaling mechanism,such as an LED 1002, 1004, 1006. The LED may be positioned at the frontof the device, for example, on the front of the housing or canister1002, 1004, 1006 of the device such that the visual indicator (e.g.,light) may be seen by a user of the device.

In some examples, the adapter may be configured to position the one ormore sensors contained within the sensor device in a predeterminedrelation or manner to the medicament device. FIG. 11 demonstrates anon-limiting example of how a product-specific adapter can position theone or more sensors contained within the sensor device in relation tothe medicament device. In this example, the sensor device comprises anaccelerometer and a barometer. In order for the accelerometer toproperly measure, for example, shake parameters of the medicamentdevice, the accelerometer may need to be positioned along the centerlineof the medicament canister. The adapter may function, inter alia, toposition the accelerometer along the centerline of the medicamentcanister. Advantageously, the product-specific adapter may be designedin such a way as to position the accelerometer along the centerline of aspecific medicament canister, regardless of the arrangement of theaccelerometer within the sensor device. Thus, the present inventionallows for the use of a universal sensor device with any configurationor arrangement of sensors with virtually any medicament device. Althougha specific example using an accelerometer has been described, it shouldbe understood that the adapter may be used in a similar fashion toposition any sensor in a particular configuration with any medicamentdevice.

In some cases, the methods and devices include one or more sensors forthe detection of one or more parameters of the medicament device. Theone or more parameters may include one or more shake parameters, one ormore actuation parameters, one or more inhalation airflow parameters, orany combination thereof. In some cases, the one or more sensorscontained within the sensor device detects if the medicament devicemeets or exceeds a predetermined threshold of the one or moreparameters. For example, the one or more sensors may sense or detect ifthe medicament device has been shaken properly prior to actuation by,e.g., detecting one or more shake parameters. In another example, theone or more sensors may sense or detect if the medicament device hasbeen actuated properly by, e.g., detecting one or more actuationparameters. In some cases, when each of the one or more parameters havemet their respective thresholds, the medicament device, when actuated,may deliver an intended dosage range of a drug. In some cases, the oneor more sensors may be used to detect when a predetermined threshold ofone or more parameters have been met. Each of the one or more parametersmay have a predetermined threshold that is specific for a particularmedicament device, therefore, in some instances, the one or more sensorsmay be used to detect if each of the one or more parameters hasindividually reached its respective threshold. In some cases, thedevices provide one or more outputs when a predetermined threshold ofeach of the one or more parameters has been met or exceeded. In somecases, the devices do not provide an output unless each of the one ormore parameters has individually reached its respective threshold.Different medicament devices may have different requirements for propershaking and actuation. Thus, the sensor device alone or in combinationwith the adapter may be pre-programmed and customized to operate with aspecific medicament device. The sensor device alone or in combinationwith the adapter may be pre-programmed to detect a particular set ofthresholds based on the medicament device and the formulation containedtherein.

Any type of sensor may be utilized with the sensor devices describedherein. For example, the sensor may be an airflow sensor (e.g., athermistor or pressure sensor), an integrated flow sensor, a position ordisplacement sensor, a rate sensor, a tilt sensor, a touch sensor (e.g.,an electrode, a capacitive or resistive touch sensor), a shake sensor(e.g., accelerometer), a magnetometer, a global positioning system (GPS)chip, an ambient light sensor, a sensor capable of detecting more thanone parameter, and any combination thereof. The selection of thesensor(s) to be used with the medicament device will be dependent on theparameters that will be detected.

In some cases, the one or more sensors detect one or more shakeparameters of the medicament device. In some cases, the one or moresensors detect if the medicament device meets or exceeds a predeterminedthreshold of each of the one or more shake parameters of the medicamentdevice. The one or more shake parameters may include shake duration,shake angle, shake frequency, shake-to-fire interval, or any combinationthereof. The term “shake duration” as used herein may refer to thelength of time the medicament device is shaken. Shake duration mayinclude from about 1 second to about 30 seconds. For examples, shakeduration may include about 1 second, 2 seconds, 3 seconds, 4 seconds, 5seconds, 6, seconds, 7 seconds, 8 seconds, 9 seconds, 10 seconds, 11seconds, 12 seconds, 13 seconds, 14 seconds, 15 seconds, 20 seconds, 25seconds, 30 seconds or greater.

The term “shake angle” as used herein may refer to the angle of thecanister of the medicament device during shaking as measured from itsvertical axis. For example, a shake angle of 90 degrees would includeshaking the canister horizontally. Shake angle may include from about 50degrees to about 150 degrees. For examples, shake angle may includeabout 50 degrees, 60 degrees, 70 degrees, 80 degrees, 90 degrees, 100degrees, 110 degrees, 120 degrees, 130 degrees, 140 degrees, 150 degreesor greater.

The term “shake frequency” as used herein may refer to the number oftimes (cycles) the medicament device is shaken in a given time period.Shake frequency may be measured in Hertz (Hz) which is defined as thenumber of cycles in 1 second. Shake frequency may include from about 1.0Hz to about 5.0 Hz. For examples, shake frequency may be about 1.0 Hz,1.5 Hz, 2.0 Hz, 2.5 Hz, 3.0 Hz, 3.5 Hz, 4.0 Hz, 4.5 Hz, 5.0 Hz orgreater.

The term “shake-to-fire interval” as used herein may refer to the lengthof time that occurs between the end of a shaking regimen and theactuation of the medicament device. Shake-to-fire interval may be fromabout 0 seconds to about 30 seconds. For examples, shake-to-fireinterval may be about 0 seconds (i.e., immediate actuation aftershaking), 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, 6,seconds, 7 seconds, 8 seconds, 9 seconds, 10 seconds, 11 seconds, 12seconds, 13 seconds, 14 seconds, 15 seconds, 20 seconds, 25 seconds, 30seconds or greater.

In some cases, the one or more sensors as described herein may be usedto monitor a shaking regimen. A shaking regimen may include one or moreshake parameters, including one or more of shake duration, shake angle,shake frequency, and shake-to-fire interval. The shaking regimen may bethe specific combination of the one or more shake parameters that arerequired to be performed on the medicament device in order to deliver,upon actuation of the medicament device, an intended dosage range of adrug. The shaking regimen may be specific for a particular medicamentdevice and may be at least partly dependent on the formulation of thedrug, one or more characteristics of the medicament device, the volumeof the metering valve, the relative mixing efficiency of the drugparticles in the suspension with the excipient(s) and/or propellant(s),or any combination thereof. The shaking regimen may be affected by thecomposition of the formulation present in the canister (e.g., the numberof excipients present with the drug in the formulation or the specificcomposition of the excipients present in the formulation). Therefore,different products each including the same drug may require verydifferent shaking regimens to deliver an intended dosage range.

In some aspects, the methods described herein involve performing ashaking regimen on the medicament device, monitoring one or more shakeparameters of the shaking regimen, and actuating the medicament devicewhen a predetermined threshold of the one or more shake parameters hasbeen reached or exceeded. For example, if a shaking regimen included ashake duration of 5 seconds, a shake angle of 60 degrees, and a shakefrequency of 2.0 Hz, the medicament device would ideally be actuatedafter all three shake parameters of the shaking regimen had beenreached. In some cases, if one or more of the shake parameters is notmet before actuation of the medicament device, the delivered dose of thedrug may be different, in some cases substantially different, than theintended target dose.

In some cases, the one or more sensors may detect one or more actuationparameters of the medicament device. For example, the one or moresensors may detect if the medicament device has been properly actuated(e.g., held in a fully actuated state for a defined period of time). Theterm “actuation” may refer to the act of compressing the canister of amedicament device for a period of time to release a substance containedwithin the canister or the holder. Actuation of the medicament device,for example, may release a single dose of a formulation containedtherein. The one or more sensors may be designed to detect if themedicament device has been only partially actuated, which may indicatethat an intended dosage range of a drug has not been released. The oneor more actuation parameters may include, without limitation,compression velocity, compression acceleration, actuation hold time,decompression velocity, decompression acceleration, actuation strokelength, and any combination thereof.

“Compression velocity” as used herein may refer to the speed with whichthe medicament device is compressed (e.g., the speed with which a userpushes or compresses the canister or nasal actuator during actuation).Compression velocity may be from about 10 mm/s to about 100 mm/s. Forexample, compression velocity may be about 10 mm/s, 15 mm/s, 20 mm/s, 25mm/s, 30 mm/s, 35 mm/s, 40 mm/s, 45 mm/s, 50 mm/s, 55 mm/s, 60 mm/s, 65mm/s, 70 mm/s, 75 mm/s, 80 mm/s, 85 mm/s, 90 mm/s, 95 mm/s, 100 mm/s orgreater than 100 mm/s.

“Compression acceleration” as used herein may refer to the rate ofchange in velocity per unit time of the canister or nasal actuatorduring compression. Compression acceleration may be from about 500 mm/s²to about 4000 mm/s². For example, compression acceleration may be about500 mm/s², 600 mm/s², 700 mm/s², 800 mm/s², 900 mm/s², 1000 mm/s², 1100mm/s², 1200 mm/s², 1300 mm/s², 1400 mm/s², 1500 mm/s², 1600 mm/s², 1700mm/s², 1800 mm/s², 1900 mm/s², 2000 mm/s², 2100 mm/s², 2200 mm/s², 2300mm/s², 2400 mm/s², 2500 mm/s², 2600 mm/s², 2700 mm/s², 2800 mm/s², 2900mm/s², 3000 mm/s², 3100 mm/s², 3200 mm/s², 3300 mm/s², 3400 mm/s², 3500mm/s², 3600 mm/s², 3700 mm/s², 3800 mm/s², 3900 mm/s², 4000 mm/s² orgreater than 4000 mm/s².

“Actuation hold time” as used herein may refer to the amount of time amedicament device is held in its fully actuated state. “Fully actuated”may refer to maximal compression of the canister of a medicament device.Actuation of a medicament device may include compression of a medicamentdevice and may include an “actuation hold time window”, for example, aperiod of time in which a medicament device is held in its fullyactuated state. An actuation hold time window may be from about 0seconds to about 30 seconds. For example, an actuation hold time windowmay be about 0 seconds (immediate release), 1 second, 2 seconds, 3seconds, 4 seconds, 5 seconds, 6 seconds, 7 seconds, 8 seconds, 9seconds, 10 seconds, 11 seconds, 12 seconds, 13 seconds, 14 seconds, 15seconds, 16 seconds, 17 seconds, 18 seconds, 19 seconds, 20 seconds, 21seconds, 22 seconds, 23 seconds, 24 seconds, 25 seconds, 26 seconds, 27seconds, 28 seconds, 29 seconds, 30 seconds or greater than 30 seconds.

In some cases, the one or more sensors may detect the decompressionvelocity. “Decompression velocity” as used herein may refer to the speedwith which the medicament device is decompressed (e.g., speed with whicha user releases or decompresses the canister or nasal actuator afteractuation). Decompression velocity may be from about 10 mm/s to about100 mm/s. For example, decompression velocity may be about 10 mm/s, 15mm/s, 20 mm/s, 25 mm/s, 30 mm/s, 35 mm/s, 40 mm/s, 45 mm/s, 50 mm/s, 55mm/s, 60 mm/s, 65 mm/s, 70 mm/s, 75 mm/s, 80 mm/s, 85 mm/s, 90 mm/s, 95mm/s, 100 mm/s or greater than 100 mm/s.

In some cases, the one or more sensors may detect the decompressionacceleration. “Decompression acceleration” as used herein may refer tothe rate of change of velocity per unit time during decompression of thecanister or nasal actuator during decompression. Decompressionacceleration may be from about 500 mm/s² to about 4000 mm/s². Forexample, decompression acceleration may be about 500 mm/s², 600 mm/s²,700 mm/s², 800 mm/s², 900 mm/s², 1000 mm/s², 1100 mm/s², 1200 mm/s²,1300 mm/s², 1400 mm/s², 1500 mm/s², 1600 mm/s², 1700 mm/s², 1800 mm/s²,1900 mm/s², 2000 mm/s², 2100 mm/s², 2200 mm/s², 2300 mm/s², 2400 mm/s²,2500 mm/s², 2600 mm/s², 2700 mm/s², 2800 mm/s², 2900 mm/s², 3000 mm/s²,3100 mm/s², 3200 mm/s², 3300 mm/s², 3400 mm/s², 3500 mm/s², 3600 mm/s²,3700 mm/s², 3800 mm/s², 3900 mm/s², 4000 mm/s² or greater than 4000mm/s².

In some cases, the one or more sensors may detect an actuation strokelength. “Actuation stroke length” as used herein may refer to themaximum amount the medicament device is compressed during actuation. Insome cases, the actuation stroke length is the mechanical compressionlimit for the medicament device. Actuation stroke length may be fromabout 3 mm to about 20 mm. For example, actuation stroke length may beabout 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm or greater than 20mm.

In some cases, the one or more sensors may detect one or more inhalationairflow parameters. For example, the one or more sensors may detect oneor more inhalation airflow parameters, for example, during inhalation ofa delivered amount of a formulation by a user of the medicament device.In some cases, the one or more sensors may detect inspiratory airflowrate. “Inspiratory airflow rate” as used herein may refer to the speedof airflow during inspiration. Inspiratory airflow rate may be areadout, for example, for the strength of a breath or a sniff. Theinspiratory airflow rate may be from about 30 liters/minute to about 100liters/minute depending on the flow resistance of the medicament deviceand the breathing capability of the user. For example, the inspiratoryairflow rate may be about 30 liters/minute, 35 liters/minute, 40liters/minute, 45 liters/minute, 50 liters/minute, 55 liters/minute, 60liters/minute, 65 liters/minute, 70 liters/minute, 75 liters/minute, 80liters/minute, 85 liters/minute, 90 liters/minute, 95 liters/minute, 100liters/minute or greater than 100 liters/minute.

In some cases, the one or more sensors may detect inhaled volume.“Inhaled volume” as used herein may refer to the volume of air inhaledduring a breath or a sniff. The inhaled volume may be about from about0.5 liters to about 5 liters. For example, the inhaled volume may beabout 0.5 liters, about 1.0 liter, about 1.5 liters, about 2.0 liters,about 2.5 liters, about 3.0 liters, about 3.5 liters, about 4.0 liters,about 4.5 liters, about 5.0 liters or greater than 5.0 liters.

In some cases, the one or more sensors may detect inflow velocity.“Inflow velocity” as used herein may refer to the velocity measured at apoint in the stream of air inhaled during a breath or sniff. In somecases, the inflow velocity may be about from about 0.1 meters/second toabout 3.0 meters/second. For example, the inflow velocity may be about0.1 meters/second, 0.2 meters/second, 0.3 meters/second, 0.4meters/second, 0.5 meters/second, 0.6 meters/second, 0.7 meters/second,0.8 meters/second, 0.9 meters/second, 1.0 meters/second, 1.1meters/second, 1.2 meters/second, 1.3 meters/second, 1.4 meters/second,1.5 meters/second, 1.6 meters/second, 1.7 meters/second, 1.8meters/second, 1.9 meters/second, 2.0 meters/second, 2.1 meters/second,2.2 meters/second, 2.3 meters/second, 2.4 meters/second, 2.5meters/second, 2.6 meters/second, 2.7 meters/second, 2.8 meters/second,2.9 meters/second, 3.0 meters/second or greater than 3.0 meters/second.

The devices described herein may further guide a user in the properusage and/or care of a medicament device. In some cases, the devicesdescribed herein may detect the expiration date of a drug containedwithin the medicament device. For example, the devices described hereinmay determine whether the date of actual usage of the drug falls insideor outside the expiration date of the drug. The devices may, by way ofexample, instruct the user that the drug contained within the medicamentdevice has expired, and may instruct the user to cease usage of the drugor to replace the drug. The expiration of the drug may be determined bythe manufacturer of the drug and may be marked on the drug productitself or the box of the drug product.

In some cases, the devices described herein may detect whether themedicament device has been properly primed prior to use. The devices maydetect the number of times the medicament device is to be actuated priorto initial use of the medicament device, and may determine whether theuser has properly primed the medicament device. In some cases, thedevices described herein may provide guidance to the user on how toproperly prime the medicament device, by, for example, informing theuser how many times the medicament device should be actuated prior toinitial use. When the devices detect that the medicament device has notbeen properly primed, the devices may alert the user. The primingregiment for a particular medicament device may be provided by themanufacturer of the medicament device, and may range from 2 to 10actuations, and in some cases from 0 to 5 actuations. Optionally, thepriming regiment may be equal to about 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or10 actuations or steps.

In some cases, the devices described herein may detect whether themedicament device has been properly re-primed, for example, after aperiod of non-use. The device may detect whether a medicament device hasnot been used for a specified period of time, and then may instruct auser to re-prime the medicament device by actuating the medicamentdevice a number of times before resuming use of the medicament device.The re-priming regiment may include from 2 to 10 actuations after about5 to 7 days of non-use. In some cases, the number of re-primingactuations is from 0 to 5 actuations. Optionally, the re-primingregiment may be equal to about 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10actuations or steps. In some cases, the duration until re-priming isfrom 0 to 30 days. Depending on the type of medicament device, theduration until re-priming (e.g., recommended duration) may be equal toabout 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 30 days, or anyvalue there in between.

In some cases, the devices described herein may provide guidance to auser such as the wait time between actuations. Proper administration ofa drug from some medicament devices may require a user to wait for aperiod of time after an actuation event before inhaling. In such cases,the devices may instruct the user to actuate the device, wait for adefined period of time, and then inhale. In some cases, the wait timebetween actuations may be from about 0 to about 60 seconds. For example,the wait time between actuations may be from about 0, 1, 2, 3, 4, 5, 6,7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25,26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43,44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, or 60seconds.

In some cases, the devices described herein may instruct the user toclean the medicament device after a specified period of use. Forexample, the devices may detect when a specified number of actuationshave occurred, and then instruct the user that a cleaning protocolshould be performed on the medicament device.

In some cases, the devices described herein produce one or more outputswhen the one or more parameters has met a predetermined threshold. Insome cases, the devices are operably coupled to an indicator or asignaling mechanism and provide an indication to the user that themedicament device is in a condition suitable for delivering an intendeddosage range of a drug. For example, when the sensor device has detectedthat one or more parameters of the medicament device has met or exceededa predetermined threshold, the sensor device may produce one or moreoutputs that includes an indication to indicate that the medicamentdevice is in a certain state or condition. For example, the sensordevice may provide an indication to the user that the medicament devicehas been properly shaken. In another example, the sensor device mayprovide an indication to the user that the medicament device has beenproperly actuated. The indication may be a visual indication, an audibleindication, or both. For example, as shown in FIG. 12A, the device mayinclude a light source, such as a light-emitting diode (LED) thatproduces a visual indication 1201 (e.g., a light) when a predeterminedthreshold of the one or more parameters has been met or exceeded. Thevisual indication may be a change in the color of the light (forexample, a red light indicates that the device is not properly shakenand a green light indicates that the device has been properly shaken).The visual indication can be the presence or absence of light (forexample, a light is off when the device has not been properly shaken andthe light switches on after the device has been properly shaken). Insome cases, the visual indication can be a flashing of a light. Thelight may be on any component of the sensor device, on the adapter, oron the medicament device itself, although generally the light ispositioned such that it is easily seen by the user. For example, thelight can be on the holder (e.g., nasal spray device, or actuator ormouthpiece of an inhaler) of the medicament device. In some cases, thelight is positioned on the medicament device such that it may be seen bythe user when the medicament device has been placed in the user's mouthwithout having to first remove the medicament device from the mouth. Insome cases, the indication is an audible indication. An audibleindication may be used, for example, when a device user is visuallyimpaired (e.g., blind, color-blind). An audible indication may be abeep, a chime, a buzz, music, or any other audible indication, as shownin FIG. 12B. In some cases, an audible indication may be the sound of avoice speaking instructions to the user, as shown in FIG. 12C. In somecases, the indication is a vibration of the device, as shown in FIG.12D. In some cases, the devices include both a visual indication and anaudible indication. In some cases, the devices include a plurality ofdifferent visual indications or a plurality of different audibleindications that may indicate different conditions of the device (e.g.,one indication indicates the device has been properly shaken and anotherindication indicates the device has been properly actuated).

In some aspects, the one or more outputs include data. The data may becollected by the sensor device, stored by the sensor device, or both. Insome cases, the data may be transmitted to and/or read from a mobiledevice (e.g., a cell phone, a tablet), a computer, a cloud applicationor any combination thereof. The data may be transmitted by any means fortransmitting data, including, but not limited to, downloading the datafrom the sensor (e.g., USB, RS-232 serial, or other industry standardcommunications protocol) and wireless transmission (e.g., Bluetooth®,ANT+, NFC, or other similar industry standard). The data may includeinformation as to the conditions and/or status of the device at the timeof actuation. For example, the data may include information on how thedevice was shaken, information on how the device was actuated,information on how the formulation was delivered to the device user(e.g., volume of air that was inhaled, etc.), information on theenvironmental conditions of the device (e.g., temperature, humidity),information regarding the date, time, and geographical location of thedevice, and the like. The information may be displayed as a report. Thereport may be displayed on the screen of a mobile device or a computer.The report may be transmitted to a healthcare provider or a caregiver.In some cases, the devices described herein may provide data including,without limitation, information about how the medicament device wasshaken (e.g., one or more shake parameters such as shake angle, shakefrequency, etc.), when the medicament device was actuated (e.g., withinthe shake-to-fire interval, etc.), how the medicament device wasactuated (e.g., one or more actuation parameters such as compressionvelocity, actuation hold time, etc.), and when and how the medicamentdevice was decompressed. The data may then be downloaded and provided toa healthcare provider or caregiver to assess whether the patient isproperly using the medicament device and delivering the correct dose ofdrug. In some instances, the data may be downloaded to an electronichealth record. Optionally, the data may comprise or be part of anelectronic health record. For example, the data may be uploaded to anelectronic health record of a user of the devices and methods describedherein.

The devices described herein may include one or more additionalcomponents. In some cases, the devices may include a power source, suchas a battery, one or more timers, local data storage media, othersupporting electronics such as resistors, capacitors, connectors,wireless antennae, switches, and the like. FIG. 13 depicts anon-limiting example of a workflow of a system as described herein.

In another aspect, methods and devices are provided for detecting ashake-to-fire interval for actuating an inhaler or nasal device, whereinwhen the one or more sensors detect the shake-to-fire interval, thesensor device, the adapter, or the medicament device produces one ormore outputs. In some cases, the shake-to-fire interval indicates aperiod of time during which the medicament device, when actuated, maydeliver an intended dosage range of a drug. For example, an indicationmay be provided to a medicament device user that the medicament devicehas been properly shaken and is in a condition suitable to deliver anintended dosage range of a drug upon proper actuation (i.e., theshake-to-fire interval has not expired). In some cases, theshake-to-fire interval detected by the one or more sensors includes afirst time point at the start of the shake-to-fire interval and a secondtime point at the end of the shake-to-fire interval. In some cases, theone or more sensors detect the first time point (e.g., immediately afterthe one or more sensors have detected that the medicament device hasbeen properly shaken) and the devices produce an output, such as anindicator that the medicament device is ready to be actuated. The one ormore sensors may also detect a second time point, for example, at theend of the shake-to-fire interval, that indicates the medicament deviceis no longer in a suitable condition to deliver an intended dosage rangeof a drug upon actuation. For example, if the medicament device is notactuated within a specified time frame after shaking, the formulationcontained within the medicament device may not be homogeneous andactuation of the medicament device may not provide an intended dosagerange of the drug. For example, a suspension formulation may need to beproperly shaken prior to actuation as the insoluble drug particles maysettle to the bottom of the canister. Proper shaking may re-suspend theinsoluble drug particles such that actuation of the device would deliveran intended dosage range of the drug. However, after a time period, theinsoluble drug particles will again settle to the bottom of thecanister. Therefore, actuation outside of this shake-to-fire intervalmay not deliver an intended dosage range of the drug. In some cases, theone or more sensors detect this second time point (i.e., at the end ofthe shake-to-fire interval) and the devices produce an output. In somecases, this output is another indication that the medicament device isno longer in a condition suitable to deliver an intended dosage range ofthe drug. The indication can be a visual indication or an audibleindication or both as described herein. In some cases, the presence of alight may indicate that the medicament device is ready to be actuatedand the absence of the light may indicate that the medicament device isnot ready to be actuated. In some instances, the indication is a changein color (e.g., from green to red). In some cases, the one or moresensors may detect one or more parameters of the medicament device asdescribed herein, for example, one or more shake parameters (e.g., shakeangle, shake frequency, shake duration, shake-to-fire interval). In somecases, the one or more sensors may detect when a predetermined thresholdof the one or more parameters has been met or exceeded. In some cases,the medicament device may be unable to be actuated if the shake-to-fireinterval is not detected. For example, the medicament device may belocked or otherwise prevented from being actuated outside of theshake-to-fire interval. In some cases, the medicament device may beautomatically actuated when the shake-to-fire interval is detected. Theshake-to-fire interval may vary and will be dependent on the type ofmedicament device being used, the formulation of the drug, and otherfactors. The devices described herein may be pre-programmed andcustomized to detect the appropriate shake-to-fire interval for eachmedicament device.

In another aspect, methods and devices are provided comprising one ormore sensors for detecting an actuation hold time window of a medicamentdevice, wherein when the one or more sensors detect the actuation holdtime window, the devices produce one or more outputs. The actuation holdtime window, as described herein, may include a period of time in whichthe medicament device is held in a fully actuated position. Theactuation hold time window may indicate a length of time after which themedicament device, when held in an actuated state, has delivered anintended dosage range of a drug. In some cases, the actuation hold timewindow may include a first time point at the start of the actuation holdtime window and a second time point at the end of the actuation holdtime window. In some cases, the one or more sensors may detect one ormore actuation parameters, as described herein. In some cases, the oneor more sensors may detect when a predetermined threshold of the one ormore actuation parameters has been met or exceeded, and this mayindicate that the medicament device is being held in a fully actuatedstate. The actuation hold time window may be dependent on the type ofthe medicament device, the formulation of the drug, and other factors.In some cases, the devices described herein may produce one or moreoutputs, such as an indication, when a second time point (e.g., at theend) of the actuation hold time window has been detected. The indicationmay be a visual indication, an audible indication or both as describedherein. The one or more sensors may further detect one or moreadditional parameters of the medicament device, such as shake parametersor inhalation airflow parameters.

In some aspects, methods are provided for using the devices describedherein. In one aspect, a method is provided comprising: (a) shaking themedicament device, wherein the shaking comprises one or more shakeparameters; and (b) actuating the medicament device when a predeterminedthreshold of the one or more shake parameters is met, wherein when theone or more sensors detect that the predetermined threshold has beenmet, the device produces one or more outputs.

In another aspect, a method is provided comprising: (a) compressing themedicament device for a period of time, wherein the period of timecomprises an actuation hold time window; and (b) decompressing themedicament device when the device produces an output, wherein when theone or more sensors detect the end of the actuation hold time window,the device produces the output.

FIG. 14 depicts a non-limiting workflow of a method of using the devicesas described herein. It should be understood that FIG. 14 is merelyintended to be illustrative and variations on the methods of using thedevices are also envisioned herein. Variations on the methods may bedependent on the various aspects of the devices, as have been describedin detail throughout the disclosure. For example, the order of theworkflow may be modified or steps may be added or subtracted from themethod to accommodate the systems.

The sensor device may guide or instruct a user through each of the oneor more parameters of a medicament device described throughout suchthat, when the user follows the instructions of the device, the accuracyof an emitted dosage may be improved. FIGS. 15A-E depict a non-limitingexample of how a sensor device as provided by the disclosure may guide auser of a medicament device to deliver the correct dose of a drug. FIG.15A depicts a medicament device 1500 with a sensor device and adapter1501 affixed thereto. The sensor device 1501 may provide an output 1505(e.g., an audible indication) to the user indicating that the medicamentdevice 1500 is ready to be shaken as shown in FIG. 15B. The user maythen shake 1503 the medicament device 1500. As shown in FIG. 15C, thesensor device 1501 may sense when the medicament device has beenproperly shaken (e.g., a predetermined threshold of one or more shakeparameters has been met). The device may then provide an output 1507 tothe user indicating that the shake-to-fire interval has begun and thatthe user should begin to inhale. As shown in FIG. 15D, the sensor devicemay then provide an output 1509 to the user indicating to the user toactuate the medicament device 1500. The user may then actuate themedicament device by compressing and holding down the canister whichthen delivers a dosage of a drug 1511 to the user. As shown in FIG. 15E,the sensor device 1501 may then provide an output 1513 to the user toindicate that the canister should be decompressed.

The present disclosure further provides computer control systems thatare programmed to implement the methods of the disclosure. FIG. 16 showsa computer system 1601 that is programmed or otherwise configured tooperate a sensor device. The computer system 1601 can regulate variousaspects of sensor devices, systems and methods of the presentdisclosure, such as, for example, automatically processing parametersassociated with a medicament device as presently described herein. Thecomputer system 1601 can execute a guidance program configured to guidea user to properly use the medicament device. The computer system 1601can be an electronic device (e.g. sensor device, adapter, etc) of a useror a computer system that is remotely located with respect to theelectronic device. The computer system 1601 can be a part of a sensordevice or an adapter, individually or collectively. The electronicdevice can be a mobile electronic device such as a phone, IPAD, tablet,etc.

The computer system 1601 includes a central processing unit (CPU, also“processor” and “computer processor” herein) 1605, which can be a singlecore or multi core processor, or a plurality of processors for parallelprocessing. The computer system 1601 also includes memory or memorylocation 1610 (e.g., random-access memory, read-only memory, flashmemory), electronic storage unit 1615 (e.g., hard disk), communicationinterface 1620 (e.g., network adapter) for communicating with one ormore other systems, and peripheral devices 1625, such as cache, othermemory, data storage and/or electronic display adapters. The memory1610, storage unit 1615, interface 1620 and peripheral devices 1625 arein communication with the CPU 1605 through a communication bus (solidlines), such as a motherboard. The storage unit 1615 can be a datastorage unit (or data repository) for storing data. The computer system1601 can be operatively coupled to a computer network (“network”) 1630with the aid of the communication interface 1620. The network 1630 canbe the Internet, an internet and/or extranet, or an intranet and/orextranet that is in communication with the Internet. The network 1630 insome cases is a telecommunication and/or data network. The network 1630can include one or more computer servers, which can enable distributedcomputing, such as cloud computing. The network 1630, in some cases withthe aid of the computer system 1601, can implement a peer-to-peernetwork, which may enable devices coupled to the computer system 1601 tobehave as a client or a server.

The CPU 1605 can execute a sequence of machine-readable instructions,which can be embodied in a program or software. The instructions may bestored in a memory location, such as the memory 1610. The instructionscan be directed to the CPU 1605, which can subsequently program orotherwise configure the CPU 1605 to implement methods of the presentdisclosure. Examples of operations performed by the CPU 1605 can includefetch, decode, execute, and writeback.

The CPU 1605 can be part of a circuit, such as an integrated circuit.One or more other components of the system 1601 can be included in thecircuit. In some cases, the circuit is an application specificintegrated circuit (ASIC).

The storage unit 1615 can store files, such as drivers, libraries andsaved programs. The storage unit 1615 can store user data, e.g., userpreferences and user programs. The computer system 1601 in some casescan include one or more additional data storage units that are externalto the computer system 1601, such as located on a remote server that isin communication with the computer system 1601 through an intranet orthe Internet.

The computer system 1601 can communicate with one or more remotecomputer systems through the network 1630. For instance, the computersystem 1601 can communicate with a remote computer system of a user(e.g., in need of medication). Examples of remote computer systemsinclude personal computers (e.g., portable PC), slate or tablet PC's(e.g., Apple® iPad, Samsung® Galaxy Tab), telephones, Smart phones(e.g., Apple® iPhone, Android-enabled device, Blackberry®), or personaldigital assistants. The user can access the computer system 1601 via thenetwork 1630.

Methods as described herein can be implemented by way of machine (e.g.,computer processor) executable code stored on an electronic storagelocation of the computer system 1601, such as, for example, on thememory 1610 or electronic storage unit 1615. The machine executable ormachine readable code can be provided in the form of software. Duringuse, the code can be executed by the processor 1605. In some cases, thecode can be retrieved from the storage unit 1615 and stored on thememory 1610 for ready access by the processor 1605. In some situations,the electronic storage unit 1615 can be precluded, andmachine-executable instructions are stored on memory 1610.

The code can be pre-compiled and configured for use with a machinehaving a processer adapted to execute the code, or can be compiledduring runtime. The code can be supplied in a programming language thatcan be selected to enable the code to execute in a pre-compiled oras-compiled fashion.

Aspects of the systems and methods provided herein, such as the computersystem 1601, can be embodied in programming. Various aspects of thetechnology may be thought of as “products” or “articles of manufacture”typically in the form of machine (or processor) executable code and/orassociated data that is carried on or embodied in a type of machinereadable medium. Machine-executable code can be stored on an electronicstorage unit, such as memory (e.g., read-only memory, random-accessmemory, flash memory) or a hard disk. “Storage” type media can includeany or all of the tangible memory of the computers, processors or thelike, or associated modules thereof, such as various semiconductormemories, tape drives, disk drives and the like, which may providenon-transitory storage at any time for the software programming. All orportions of the software may at times be communicated through theInternet or various other telecommunication networks. Suchcommunications, for example, may enable loading of the software from onecomputer or processor into another, for example, from a managementserver or host computer into the computer platform of an applicationserver. Thus, another type of media that may bear the software elementsincludes optical, electrical and electromagnetic waves, such as usedacross physical interfaces between local devices, through wired andoptical landline networks and over various air-links. The physicalelements that carry such waves, such as wired or wireless links, opticallinks or the like, also may be considered as media bearing the software.As used herein, unless restricted to non-transitory, tangible “storage”media, terms such as computer or machine “readable medium” refer to anymedium that participates in providing instructions to a processor forexecution.

Hence, a machine readable medium, such as computer-executable code, maytake many forms, including but not limited to, a tangible storagemedium, a carrier wave medium or physical transmission medium.Non-volatile storage media include, for example, optical or magneticdisks, such as any of the storage devices in any computer(s) or thelike, such as may be used to implement the databases, etc. shown in thedrawings. Volatile storage media include dynamic memory, such as mainmemory of such a computer platform. Tangible transmission media includecoaxial cables; copper wire and fiber optics, including the wires thatcomprise a bus within a computer system. Carrier-wave transmission mediamay take the form of electric or electromagnetic signals, or acoustic orlight waves such as those generated during radio frequency (RF) andinfrared (IR) data communications. Common forms of computer-readablemedia therefore include for example: a floppy disk, a flexible disk,hard disk, magnetic tape, any other magnetic medium, a CD-ROM, DVD orDVD-ROM, any other optical medium, punch cards paper tape, any otherphysical storage medium with patterns of holes, a RAM, a ROM, a PROM andEPROM, a FLASH-EPROM, any other memory chip or cartridge, a carrier wavetransporting data or instructions, cables or links transporting such acarrier wave, or any other medium from which a computer may readprogramming code and/or data. Many of these forms of computer readablemedia may be involved in carrying one or more sequences of one or moreinstructions to a processor for execution.

The computer system 1601 may be in communication with various otherdevices 1635. Although one device 1635 is shown, the computer system1601 may be in communication with a plurality of other devices, such asadapters, or medicament devices. For example, the medicament device maycomprise wired or wireless communication capabilities (e.g., RFID chip,etc). In such instances, a sensor device as referred to herein (e.g.,with or without an adapter) may communicate with a medicament device.

The computer system 1601 can include or be in communication with anelectronic display (not shown) that comprises a user interface (UI) forproviding, for example, one or more controls or input elements to enablea user to control the sensor device 1635. Examples of UI's include,without limitation, a graphical user interface (GUI) and web-based userinterface.

Methods and systems of the present disclosure can be implemented by wayof one or more algorithms. An algorithm can be implemented by way ofsoftware upon execution by the central processing unit 1605. Thealgorithm may be executed in some instances once an instruction from auser is received (e.g., through the computer system 1601), and mayeffect operation of the sensor device 1635. The algorithm can receiveone or more signals through one or more sensors of the sensor device1635, and in some cases adjust the manner in which guidance is providedto a user through the sensor device 1635.

The algorithm can execute or implement various aspects of methodsprovided herein. For example, the algorithm may be executed to generatethe guidance (e.g. in form of data or signals) which is thencommunicated to a user via visual or auditory modes. The sensor device(e.g. processing unit of the sensor device) may further process theinstructions to implement or execute various aspects of the methods.

In some instances, the algorithm may be programmed, or otherwiseconfigured to determine or select appropriate parameters for using themedicament device to provide an effective usage session (e.g., of usingthe medicament device or dispensing a drug formulation). In someinstances, the algorithm may be executed to provide, or guide a useraccording to manufacturer suggested parameters such that an inhalationsession provided to a user is better, or more efficient to achieve adesired effect (e.g., in accordance with manufacturer standards).Optionally, the algorithm may be executed to provide furtherinstructions to the sensor device. For example, via execution of thealgorithm, instructions may be generated that instruct a processor onboard the sensor device to receive parameters for guiding a user to usea medicament device, e.g., from an adapter via a wireless or wired mode.As another example, via execution of the algorithm, instructions may begenerated that instruct a processor on board the sensor device toreceive parameters from other sources, such as directly from amedicament device (e.g., via RFID chip, etc) or from the internet. Forexample, the sensor device may be programmable or may communicate with aserver (e.g., cloud based server) which comprises parametersconfigurable by a user, guardians, or a healthcare provider. The user,guardian, or healthcare provider may be able to store appropriateparameters online which may be read by the sensor device as describedthroughout, which may process and use the parameters to guide a user.

In some instances, the algorithms may be executed by a third party. Forexample, the algorithms may be executed by a healthcare provider. Thehealthcare provider may provide an input (e.g. an instruction) to acloud based platform, which may generate parameters that are transmittedto a user's sensor device (and/or mobile device in communication withthe sensor device) which then executes the algorithm. Execution of thealgorithm may further generate instructions that are transmitted to asensor device. The instructions may instruct a processor on board thesensor device to run a user guidance program, and an indicator (e.g.,visual or auditory indicator) may then output an indication to guide auser.

The computer system 1601 can execute an algorithm to provide a set ofinstructions. For example, relevant parameters for a medicament devicemay be transmitted (e.g. wired or wirelessly) to a communication moduleof a sensor device 1635 and be received by a processing unit (e.g., ofthe sensor device). The processing unit may or may not process the setof parameters and further instruct an indicator for transmission one ormore indications to guide a user in using a medication device.

As used herein A and/or B encompasses one or more of A or B, andcombinations thereof such as A and B. It will be understood thatalthough the terms “first,” “second,” “third” etc. may be used herein todescribe various elements, components, regions and/or sections, theseelements, components, regions and/or sections should not be limited bythese terms. These terms are merely used to distinguish one element,component, region or section from another element, component, region orsection. Thus, a first element, component, region or section discussedbelow could be termed a second element, component, region or sectionwithout departing from the teachings of the present invention.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising,” or “includes” and/or “including,” when used in thisspecification, specify the presence of stated features, regions,integers, steps, operations, elements and/or components, but do notpreclude the presence or addition of one or more other features,regions, integers, steps, operations, elements, components and/or groupsthereof.

Furthermore, relative terms, such as “lower” or “bottom” and “upper” or“top” may be used herein to describe one element's relationship to otherelements as illustrated in the figures. It will be understood thatrelative terms are intended to encompass different orientations of theelements in addition to the orientation depicted in the figures. Forexample, if the element in one of the figures is turned over, elementsdescribed as being on the “lower” side of other elements would then beoriented on the “upper” side of the other elements. The exemplary term“lower” can, therefore, encompass both an orientation of “lower” and“upper,” depending upon the particular orientation of the figure.Similarly, if the element in one of the figures were turned over,elements described as “below” or “beneath” other elements would then beoriented “above” the other elements. The exemplary terms “below” or“beneath” can, therefore, encompass both an orientation of above andbelow.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. Numerous differentcombinations of embodiments described herein are possible, and suchcombinations are considered part of the present disclosure. In addition,all features discussed in connection with any one embodiment herein canbe readily adapted for use in other embodiments herein. It is intendedthat the following claims define the scope of the invention and thatmethods and structures within the scope of these claims and theirequivalents be covered thereby.

EXAMPLES

The following examples are given for the purpose of illustrating variousembodiments of the invention and are not meant to limit the presentinvention in any fashion. The present examples, along with the methodsdescribed herein are presently representative of preferred embodiments,are exemplary, and are not intended as limitations on the scope of theinvention. Changes therein and other uses which are encompassed withinthe spirit of the invention as defined by the scope of the claims willoccur to those skilled in the art.

Example 1. Sensor Device for Use with an Inhaler Device

FIGS. 17A-D depict a non-limiting example of a sensor device 1700 thatmay be suitable for use with an inhaler device. FIG. 17A depicts a topview of the sensor device. The sensor device 1700 may include one ormore sensors such as an airflow sensor 1710 (e.g., thermistor) and atouch sensor 1702 (e.g., electrode). The sensor device 1700 may furtherinclude one or more indicators, such as a multi-colored LED 1704 forproviding a visual indication. The one or more indicators 1704 may beoperably coupled to the sensor device 1700 such that when the one ormore sensors 1702, 1710 detect a predetermined threshold of one or moreparameters of the medicament device, the sensor device 1700 transmits anoutput to the indicator 1704. The sensor device 1700 may further includeone or more contacts for downloading or extracting data from the sensordevice 1708. The electronics and working components of the sensor device1700 may be found in, for example, a raw printed circuit board 1706.FIG. 17B depicts a side view of the sensor device 1700. The sensordevice 1700 may include a potting material 1712 to protect and/or hidethe electronics and the working components of the sensor device 1700.FIG. 17C depicts a bottom view of the sensor device 1700. The sensordevice may include a high-tack adhesive coating 1714, a microcontrollerunit (MCU) 1716, an additional sensor such as a shake sensor 1718 (e.g.,3-axis accelerometer), and a power source 1720 (e.g., solid statebattery). FIG. 17D depicts an example of the sensor device 1700 affixedto the canister of an inhaler device 1701.

In one example, a user picks up an inhaler device that includes thesensor device affixed to the top of the inhaler device and touches thetouch sensor to awaken it. The user next begins to shake the inhalerdevice if the inhaler device contains a suspension formulation. In somecases, when the user has shaken the inhaler device at the angle,frequency, and duration appropriate for the particular formulation, thesensor device stores the data reflecting the shaking parameters employedby the user and produces an output that indicates by means of anindicator that the inhaler device is ready to be actuated. In oneexample, the indicator is a light, such as a LED. In one instance, theindicator is a LED light that remains on during the shake-to-fireinterval. In another instance, the indicator is a LED light that blinksduring the shake-to-fire interval. In some cases, when the sensor deviceproduces an output that indicates by means of an indicator the beginningof the shake-to-fire interval, the user then compresses the inhalerdevice canister to actuate the inhaler device. In some cases, the sensordevice captures and stores the actuation parameter data produced whenthe user actuates the inhaler device during the shake-to-fire interval.In some cases, when the user has fully compressed the canister, thesensor device produces an output that may be a second indicator toindicate the beginning of the actuation hold time window. In some cases,this indicator is a light, such as a LED. In one instance, the indicatoris an LED light that remains on during the actuation hold time window.In another instance, the indicator is an LED light that blinks duringthe actuation hold time window. In another instance, the output is anindicator that is audible, such as a chirp, a beep, a tone, or avibration. In some cases, the audible indicator remains on during theactuation hold time window. In some cases, at the end of the actuationhold time window, the sensor device produces an output that indicates bymeans of an indicator that the inhaler device canister valve has beenheld open by means of compression for the duration of the actuation holdtime window sufficiently long enough to allow for the intended dosagerange of a drug to be emitted from the inhaler device. In one instance,this output may be the turning off or absence of the LED light thatturned on or blinked during the actuation hold time window. In anotherinstance, this output may be audible, or a turning off or absence of asound. In another instance, this output may be a vibration or absence ofa vibration.

In some cases, the sensor device includes a counter to record the numberof times an inhaler device has been actuated. In one example, a userpicks up an inhaler device that includes a sensor device affixed to thetop of it and touches the sensor device to awaken it. In some cases, thesensor device produces an output that is an indication to indicate thatthe inhaler device should be primed. In some cases, when the sensordevice has not been awakened in a prescribed amount of time, the sensordevice produces an output that is an indication to indicate that theinhaler device should be re-primed. In some cases, if the user isholding the inhaler device at an angle or orientation that willnegatively impact delivery of the intended dosage range of the drug,such as a user holding the inhaler device upside down, the sensor deviceproduces an output that is an indication to indicate that the usershould re-orient the inhaler device. In some cases, the indicationproduced is visual, audible, or the absence of a visual or audibleindicator.

In another example, a user picks up an inhaler device that includes asensor device affixed to the top of it and touches the sensor device'stouch sensor to awaken it. In some cases, the sensor device stores thenumber of times the inhaler device has been actuated. In some cases, thesensor device produces an output that is an indication to indicate whenthe inhaler device has expired, should be cleaned, has limited dosesremaining, has exceeded the doses available in the device, and anycombination of one or more thereof. In some cases, the indication isvisible, audible, or a combination thereof. In some cases, the visibleindication is a light or the absence of light. In some cases, theindication is a sound or the absence of sound. In some cases, theindication is a vibration or the absence of a vibration.

In some cases, the sensor device's output is data that is collected andstored by the sensor device. In some cases, the data is transmitted toor read from a mobile device, a computer, a cloud application or anycombination thereof.

Example 2. Sensor Device for Use with a Nasal Device

A user picks up a nasal spray device that includes the sensor deviceaffixed to the nasal device's bottle, pump, or actuator nozzle tip andtouches the touch sensor to awaken it. The user next begins to shake thenasal device if the nasal device contains a suspension formulation. Insome cases, when the user has shaken the nasal device at the angle,frequency, and duration appropriate for the particular formulation, thesensor device stores the data reflecting the shaking parameters employedby the user and produces an output that indicates by means of anindicator that the nasal device is ready to be actuated. In some cases,the indicator is a light, such as an LED. In one instance, the indicatoris an LED light that remains on during the shake-to-fire interval. Inanother instance, the indicator is an LED light that blinks during theshake-to-fire interval. In some cases, when the sensor device producesan output that indicates by means of an indicator the beginning of theshake-to-fire interval, the user then compresses the nasal device's pumpby pressing on the bottom of the nasal device's bottle relative to thenasal device's nozzle tip to actuate the nasal device. In some cases,the sensor device captures and stores the actuation parameter dataproduced when the user actuates the nasal device during theshake-to-fire interval. In some cases, when the user has fullycompressed the pump, the sensor device produces an output that may be asecond indicator to indicate the beginning of the actuation hold timewindow. In some cases, this indicator is a light, such as an LED. In oneinstance, the indicator is an LED light that remains on during theactuation hold time window. In another instance, the indicator is an LEDlight that blinks during the actuation hold time window. In some cases,the output is an indicator that is audible, such as a chirp, a beep, atone, or a vibration. In some cases, the audible indicator remains onduring the actuation hold time window. In some cases, at the end of theactuation hold time window, the sensor device produces an output thatindicates by means of an indicator that the nasal device's pump has beenheld open by means of compression for the duration of the actuation holdtime window sufficiently long enough to allow for the intended dosagerange of a drug to be emitted from the nasal device. In some cases, thisoutput may be the turning off or absence of the LED light that turned onor blinked during the actuation hold time window. In some cases, thisoutput may be audible, or a turning off or absence of a sound. In somecases, this output may be a vibration or absence of a vibration.

In another example, the sensor device includes a dose counter to recordthe number of times a nasal device has been actuated. In some cases, auser picks up a nasal spray device that includes a sensor device affixedto the device's bottle, pump, or actuator nozzle tip and touches thesensor device to awaken it. In some cases, the sensor device produces anoutput that is an indication to indicate that the nasal device should beprimed. In some cases, when the sensor device has not been awakened in aprescribed amount of time, the sensor device produces an output that isan indication to indicate that the nasal device should be re-primed. Insome cases, if the user is holding the nasal device at an angle ororientation that will negatively impact delivery of the intended dosagerange of the drug, such as a user holding the nasal device upside down,the sensor device produces an output that is an indication to indicatethat the user should re-orient the nasal device. In some cases, theindication produced is visual, audible, or the absence of a visual oraudible indication.

In another example, a user picks up a nasal spray device that includes asensor device affixed to the nasal device's bottle, pump, or actuatornozzle tip and touches the sensor device to awaken it. In some cases,the sensor device stores the number of times the nasal device has beenactuated. In some cases, the sensor device produces an output that is anindication to indicate when the nasal device has expired, should becleaned, has limited doses remaining, has exceeded the doses availablein the nasal device, and any combination of one or more thereof. In somecases, the indication is visible, audible, or a combination thereof. Insome cases, the visible indication is a light or the absence of light.In some cases, the indication is a sound or the absence of sound. Insome cases, the indication is a vibration or the absence of a vibration.

In some cases, the sensor device's output is data that is collected andstored by the sensor device. In some cases, the data is transmitted toor read from a mobile device, a computer, a cloud application or anycombination thereof.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

1. A sensor device for guiding usage of a medicament device, the sensordevice comprising: a coupler for coupling to the medicament device,wherein the medicament device is selected from a plurality of differenttypes of medicament devices; one or more sensors for detecting use ofthe medicament device; a processor configured to: automatically processone or more parameters associated with the medicament device; and outputa signal based on the one or more parameters; and an indicatorconfigured to: operably receive the signal; and output a guidance to auser of the medicament device, wherein the guidance varies depending ona type of medicament device that is selected.
 2. The sensor device ofclaim 1, wherein the guidance varies based on a duration of shaking amedicament device, a shake-to-fire interval, a wait time betweenactuations, a number of priming steps, a number of re-priming steps, aduration until re-priming steps, or any combination thereof. 3.-8.(canceled)
 9. The sensor device of claim 1, wherein the guidancecomprises an auditory indication, a visual indication, or both. 10.(canceled)
 11. The sensor device of claim 1, wherein the couplercomprises a receiving port.
 12. (canceled)
 13. The sensor device ofclaim 11, wherein the receiving port is configured to removably receivea complementary protrusion of an adapter, wherein the adapter comprisesa memory storing the one or more parameters associated with themedicament device. 14.-16. (canceled)
 17. The sensor device of claim 1,wherein the one or more sensors comprise an accelerometer, a pressuresensor, a temperature sensor, a magnetometer, an ambient light sensor,or a global positioning system (GPS), or any combination thereof. 18.(canceled)
 19. The sensor device of claim 17, wherein the pressuresensor is located in a pressure sensing cavity.
 20. The sensor device ofclaim 19, wherein the pressure sensing cavity allows a bidirectionalflow of air in and out of the pressure sensing cavity.
 21. (canceled)22. (canceled)
 23. The sensor device of claim 19, wherein the pressuresensing cavity comprises an opening for coupling to a pressure tap tube.24. (canceled)
 25. (canceled)
 26. The sensor device of claim 1, whereinthe indicator comprises a speaker, a light emitting diode (LED), or avisual display, or any combination thereof.
 27. (canceled) 28.(canceled)
 29. The sensor device of claim 1, wherein the sensor devicecomprises an interface for communicating with an external device.30.-33. (canceled)
 34. An adapter for guiding usage of a medicamentdevice, the adapter comprising: a first coupler for coupling to themedicament device; a memory storing one or more parameters associatedwith the medicament device; and a second coupler for coupling to asensor device, wherein the sensor device is configured to output aguidance to a user of the medicament device. 35.-54. (canceled)
 55. Amethod of using a sensor device configured to couple to a plurality ofdifferent types of medicament devices, the method comprising: couplingthe sensor device to a first medicament device; processing one or moreparameters associated with the first medicament device; guiding usage ofthe first medicament device based on the processed one or moreparameters associated with the first medicament device; decoupling thesensor device from the first medicament device; coupling the sensordevice to a second medicament device, wherein the second medicamentdevice is the same as or differs in a type of medicament device from thefirst medicament device; processing one or more parameters associatedwith the second medicament device; and guiding usage of the secondmedicament device based on the processed one or more parametersassociated with the second medicament device, wherein guiding usage ofthe second medicament device is the same as or differs from guidingusage of the first medicament device. 56.-65. (canceled)
 66. A method ofmeasuring usage of an inhaler using one or more sensors, the methodcomprising: with aid of the one or more sensors: measuring a duration ofshaking the inhaler; measuring a duration of a time subsequent to theshaking; measuring an inhalation of a user using inhaler; measuring anactuation of the inhaler; and measuring a duration of a hold down timeof the actuation. 67.-78. (canceled)
 79. A device for monitoring usageof a medicament device, the device comprising: a) an adapter, whereinthe adapter comprises a memory storing a set of parameters specific to atype of the medicament device; and b) a sensor device separable from,and in operable communication with the adapter, wherein the sensordevice is configured to be used with a plurality of different types ofadapters each comprising a unique set of parameters specific todifferent types of medicament devices, wherein the device is configuredto produce an output based on the set of parameters. 80.-123. (canceled)124. The sensor device of claim 13, wherein the adapter comprises apressure tap tube.
 125. The sensor device of claim 13, wherein thesensor device is configured to be used with a plurality of differenttypes of adapters, each of the different types of adapters comprising aunique set of parameters specific to different types of medicamentdevices.
 126. The sensor device of claim 1, wherein the medicamentdevice comprises an oral inhaler device or a nasal inhaler device. 127.The sensor device of claim 1, wherein the guidance is a feedbackprovided to the user based on a usage of the medicament device.
 128. Thesensor device of claim 127, wherein the feedback guides the user on howto properly administer the medicament device in real-time.
 129. Thesensor device of claim 13, wherein the adapter is affixed to a housingor a canister of the medicament device.
 130. The sensor device of claim129, wherein the adapter is permanently affixed to the housing orcanister of the medicament device.
 131. The sensor device of claim 129,wherein the adapter is removably affixed to the housing or canister ofthe medicament device.
 132. The device of claim 9, wherein the visualindication comprises a presence or an absence of a light, a color changeof a light, or a flashing of a light, or any combination thereof. 133.The method of claim 66, further comprising, determining whether anintended dosage range of a drug has been delivered to the user.